[Federal Register Volume 85, Number 6 (Thursday, January 9, 2020)] [Notices] [Pages 1160-1167] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 2020-00120] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2019-N-5254] Fresenius USA, Inc., et al.; Proposal To Withdraw Approval of 249 Abbreviated New Drug Applications; Opportunity for a Hearing AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research (CDER) is proposing to withdraw approval of 249 abbreviated new drug applications (ANDAs) from multiple holders of those ANDAs and is announcing an opportunity for the ANDA holders to request a hearing on this proposal. The basis for the proposal is that these ANDA holders have repeatedly failed to file required annual reports for those ANDAs. DATES: The ANDA holders may submit a request for a hearing by February 10, 2020. Submit all data, information, and analyses upon which the request for a hearing relies by March 9, 2020. Submit electronic or written comments by March 9, 2020. ADDRESSES: The request for a hearing may be submitted by the ANDA holders by either of the following methods: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments to submit your request for a hearing. Comments submitted electronically to https://www.regulations.gov, including any attachments to the request for a hearing, will be posted to the docket unchanged. Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Because your request for a hearing will be made public, you are solely responsible for ensuring that your request does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such [[Page 1161]] as a manufacturing process. The request for a hearing must include the Docket No. FDA-2019-N-5254 for ``Fresenius USA, Inc., et al.; Proposal To Withdraw Approval of 249 ANDAs; Opportunity for a Hearing.'' The request for a hearing will be placed in the docket and publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. The ANDA holders may submit all data and analyses upon which the request for a hearing relies in the same manner as the request for a hearing except as follows: Confidential Submissions--To submit any data analyses with confidential information that you do not wish to be made publicly available, submit your data and analyses only as a written/paper submission. You should submit two copies total of all data and analyses. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of any decisions on this matter. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov or available at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. Submit both copies to the Dockets Management Staff. Any information marked as ``confidential'' will not be disclosed except in accordance with Sec. 10.20 (21 CFR 10.20) and other applicable disclosure law. Comments Submitted by Other Interested Parties: For all comments submitted by other interested parties, submit comments as follows: Electronic Submissions Submit electronic comments in the following way: Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2019-N-5254 for ``Fresenius USA, Inc., et al.; Proposal To Withdraw Approval of 249 ANDAs; Opportunity for a Hearing.'' Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with Sec. 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993-0002, 240- 402-7920, [email protected]. SUPPLEMENTARY INFORMATION: The holders of approved ANDAs to market new drugs for human use are required to submit annual reports to FDA concerning each of their approved ANDAs under Sec. Sec. 314.81 and 314.98 (21 CFR 314.81 and 314.98). The holders of the approved ANDAs listed in the following table have repeatedly failed to submit the required annual reports and have not responded to the Agency's request, sent by certified mail, for submission of the reports. ------------------------------------------------------------------------ Application No. Drug Applicant ------------------------------------------------------------------------ ANDA 020374............... Inpersol-LC/LM With Fresenius USA, Inc., Dextrose 1.5% 2637 Shadelands Dr., (calcium chloride, Walnut Creek, CA dextrose, magnesium 94598. chloride, sodium chloride, sodium lactate) Intraperitoneal Solution, 18.4 milligrams (mg)/100 milliliters (mL); 1.5 grams (g)/100 mL; 5.08 mg/100 mL; 538 mg/100 mL; 448 mg/100 mL. [[Page 1162]] Inpersol-LC/LM With Dextrose 2.5% (calcium chloride, dextrose, magnesium chloride, sodium chloride, sodium lactate) Intraperitoneal Solution, 18.4 mg/ 100 mL; 2.5 g/100 mL; 5.08 mg/100 mL; 538 mg/100 mL; 448 mg/100 mL. Inpersol-LC/LM With Dextrose 3.5% (calcium chloride, dextrose, magnesium chloride, sodium chloride, sodium lactate) Intraperitoneal Solution, 18.4 mg/ 100 mL; 3.5 g/100 mL; 5.08 mg/100 mL; 538 mg/100 mL; 448 mg/100 mL. Inpersol-LC/LM With Dextrose 4.25% (calcium chloride, dextrose, magnesium chloride, sodium chloride, sodium lactate) Intraperitoneal Solution, 18.4 mg/ 100 mL; 4.25 g/100 mL; 5.08 mg/100 mL; 538 mg/100 mL; 448 mg/100 mL. ANDA 040057............... Epinephrine and Eastman Kodak Co., Lidocaine 343 State St., Hydrochloride (HCl) Rochester, NY 14650. Injection, 0.01 mg/ mL; 2% and 0.02 mg/ mL; 2%. ANDA 040168............... Hydrocortisone and Wockhardt EU Acetic Acid Otic Operations (Swiss) Solution USP, 1%/2%. AG, c/o Morton Grove Pharmaceuticals, Inc., 6451 West Main St., Morton Grove, IL 60053. ANDA 040192............... Prednisolone Syrup, WE Pharmaceuticals, 15 mg/5 mL. Inc., 1142 D St., P.O. Box 1142, Ramona, CA 92065. ANDA 060074............... Penicillin G Pfizer Laboratories, Potassium for Division of Pfizer, Injection, Inc., 235 East 42nd 20,000,000 units/ St., New York, NY vial. 10017. ANDA 060131............... Tetracycline HCl Leiner Health Capsules. Products, Inc., 901 East 233rd St., Carson, CA 90745. ANDA 060461............... Neomycin Sulfate Ambix Laboratories, Ointment; Neomycin Division of Organics Sulfate and Corp. of America, Hydrocortisone 210 Orchard St., Acetate Ointment. East Rutherford, NJ 07073. ANDA 060521............... Humatin (paromomycin Parkedale sulfate) Capsules Pharmaceuticals, USP, Equivalent to Inc., 501 5th St., (EQ) 250 mg base. Bristol, TN 37620. ANDA 060602............... Penicillin G John D. Copanos and Potassium Powder. Co., Inc., 6110 Robinwood Rd., Baltimore, MD 21225. ANDA 060627............... Tribiotic (polymyxin Ambix Laboratories, B sulfate, Division of Organics bacitracin, and Corp. of America. neomycin sulfate) Ointment, 5000 units/ 400 units/5 mg. ANDA 060709............... Oleandomycin Roerig, Division of Injection. Pfizer, Inc., 235 East 42nd St., New York, NY 10017. ANDA 060724............... Pyocidin-HC (neomycin Kasco-EFCO sulfate, polymyxin B Laboratories, Inc., sulfate, and Cantiague Rock Rd., hydrocortisone) Otic Hicksville, NY Solution. 11802. ANDA 060769............... Tetracycline Syrup... West-Ward Pharmaceutical Corp., 465 Industrial Way West, Eatontown, NJ 07724. ANDA 060773............... Tetracycline Syrup... Leiner Health Products, Inc. ANDA 060870............... Oxytetracycline Proter S.p.A., c/o Injection. Richmar International, Inc., 1706 Birch Rd., McLean, VA 22101. ANDA 061034............... Lincomycin HCl Powder Pharmacia and Upjohn Co., 7171 Portage Rd., Kalamazoo, MI 49001. ANDA 061064............... Nystatin Ointment.... Lederle Laboratories, Division of American Cyanamid Co., 401 North Middletown Rd., Pearl River, NY 10965. ANDA 061087............... Benzocaine, Pfizer Laboratories, Oxytetracycline HCl, Division of Pfizer, and Polymyxin B Inc. Sulfate Otic Solution. ANDA 061154............... Hydrocortisone Ambix Laboratories, Acetate and Neomycin Division of Organics Sulfate Ointment. Corp. of America. ANDA 061209............... Bacitracin Ointment Do. USP, 500 units/g. ANDA 061228............... Griseofulvin Capsules Owen Laboratories, Division of Alcon Laboratories, 3737 Beltline Rd., Dallas, TX 75234. ANDA 061483............... Penicillin G Leiner Health Potassium Tablets. Products, Inc. ANDA 061518............... Bacitracin Zinc Rexall Drug Co., 135 Ointment. Chesterfield Industrial Blvd., Chesterfield, MO 63017. ANDA 061519............... Bacitracin Zinc and Do. Neomycin Sulfate Ointment. ANDA 061520............... Bacitracin Zinc and Do. Neomycin Sulfate/ Polymyxin B Sulfate Ointment. ANDA 061521............... Bacitracin Zinc, Do. Benzocaine, and Neomycin Sulfate/ Polymyxin B Sulfate Ointment. ANDA 061528............... Penicillin V American Antibiotics, Potassium Tablets Inc., 6110 Robinwood USP, EQ 250 mg base Rd., Baltimore, MD and EQ 500 mg base. 21225. ANDA 061529............... Penicillin V Do. Potassium for Oral Solution USP, EQ 125 mg base/5 mL and EQ 250 mg base/5 mL. ANDA 061532............... Ampicillin Trihydrate Leiner Health Capsules. Products, Inc. ANDA 061601............... Ampicillin for Oral American Antibiotics, Suspension USP, EQ Inc. 125 mg base/5 mL and EQ 250 mg base/5 mL. ANDA 061602............... Ampicillin Capsules Do. USP, EQ 250 mg base and EQ 500 mg base. ANDA 061632............... Ampicillin Trihydrate Chromalloy Capsules, 250 mg. Pharmaceuticals, Inc., 5353 Grosvenor Blvd., Los Angeles, CA 90066. ANDA 061652............... Oxytetracycline Warner-Lambert Co., Capsules. 201 Tabor Rd., Morris Plains, NJ 07950. ANDA 061674............... Penicillin V Leiner Health Potassium Tablets. Products, Inc. [[Page 1163]] ANDA 061697............... Griseofulvin Capsules Watson Laboratories, Inc., 311 Bonnie Cir., Corona, CA 92880. ANDA 061699............... Bacitracin Powder for Apothekernes Rx Compounding, Laboratorium A.S., c/ 5,000,000 units/ o AL Laboratories, bottle. Inc., 1 Executive Dr., Fort Lee, NJ 07024. ANDA 061701............... Tetracycline Syrup, AH Robins Co., 1211 125 mg/5 mL. Sherwood Ave., Richmond, VA 23220. ANDA 061725............... Cyclopar Warner-Lambert Co. (tetracycline HCl) Capsules USP, 250 mg and 500 mg. ANDA 061833............... Oxytetracycline HCl Pliva, c/o Transtrade Capsules, 250 mg. USA, Ltd., 515 Madison Ave., 4th Floor East, New York, NY 10022. ANDA 061847............... Bleomycin Sulfate Takasaki Plant, Injection. Nippon Kayaku Co., Ltd., 500 5th Ave., Suite 1726, New York, NY 10110. ANDA 061857............... Penicillamine Powder. Chemiewerk Homberg, c/ o Wallace Laboratories, Cranbury, NJ 08512. ANDA 061903............... Bacitracin Zinc and Ambix Laboratories, Polymyxin B Sulfate Division of Organics Ointment. Corp. of America. ANDA 061943............... Chloramphenicol Lederle Laboratories, Ophthalmic Solution, Division of American 0.5%. Cyanamid Co., 1 Cyanamid Plaza, Wayne, NJ 07470. ANDA 062032............... Erythromycin Stearate Warner-Lambert Co. Tablets, EQ 250 mg base and EQ 500 mg base. ANDA 062085............... Tetracycline HCl MM Mast and Co., 4152 Capsules, 250 mg. Ruple Rd., Cleveland, OH 44121. ANDA 062175............... Tetracycline HCl Warner-Lambert Co. Capsules, 250 mg. ANDA 062205............... Cefaclor Capsules Ceph International USP, EQ 250 mg base Corp. c/o Mova and EQ 500 mg base. Pharmaceutical Corp., State Rd #1 Jose Garrido St., Cagus, PR 00725. ANDA 062215............... Oxytetracycline HCl Lederle Laboratories, Capsules. Division of American Cyanamid Co., Pearl River, NY 10965- 1215. ANDA 062340............... Gentamicin Sulfate Pharmaceutical Injection. Specialist Association, 9852 Cowden St., Philadelphia, PA 19115. ANDA 062467............... E-Solve 2 Syosset Laboratories, (erythromycin) Inc., 150 Eileen Lotion, 2%. Way, Syosset, NY 11791. ANDA 062758............... Eryzole (erythromycin Alra Laboratories, ethylsuccinate and Inc., 3850 Clearview sulfisoxazole Ct., Gurnee, IL acetyl) Granules, EQ 60031. 200 mg base/5 mL; EQ 600 mg base/5 mL. ANDA 062869............... Cephalexin Capsules Jerome Stevens USP, EQ 500 mg base. Pharmaceuticals Inc., 60 DaVinci Dr., Bohemia, NY 11716. ANDA 062870............... Cephalexin Capsules Do. USP, EQ 250 mg base. ANDA 062944............... Clindamycin Phosphate BOCA Pharmacal, LLC., Topical Solution 3550 North West USP, EQ 1% base. 126th Ave., Coral Springs, FL 33065. ANDA 070104............... Chlorhexidine Matrix Medical Corp., Gluconate Topical 1825 South 3730 Solution, 4%. West, Salt Lake City, UT 84104. ANDA 071054............... Constilac (lactulose) Alra Laboratories, Solution, 10 g/15 mL. Inc. ANDA 071057............... Ibu-tab 200 Do. (ibuprofen) Tablets, 200 mg. ANDA 071058............... Ibu-tab (ibuprofen) Do. Tablets, 400 mg. ANDA 071059............... Ibu-tab (ibuprofen) Do. Tablets, 600 mg. ANDA 071104............... Leucovorin Calcium Xanodyne Pharmacal, Tablets, EQ 15 mg Inc., 7310 Turfway base. Rd., Suite 490, Florence, KY 41042. ANDA 071139............... Trazodone HCl American Tablets, 50 mg. Therapeutics, Inc., 89 Carlough Rd., Bohemia, NY 11716. ANDA 071140............... Trazodone HCl Do. Tablets, 100 mg. ANDA 071331............... Cholac (lactulose) Alra Laboratories, Solution, 10 g/15 mL. Inc. ANDA 071362............... Meclofenamate Sodium American Capsules USP, 50 mg. Therapeutics, Inc. ANDA 071363............... Meclofenamate Sodium Do. Capsules USP, 100 mg. ANDA 071419............... Brian Care Soapco, Inc., P.O. (chlorhexidine Box 5490, gluconate) Topical Pleasanton, CA Solution, 4%. 94566. ANDA 071429............... Clorazepate American Dipotassium Therapeutics, Inc. Capsules, 3.75 mg. ANDA 071430............... Clorazepate Do. Dipotassium Capsules, 7.5 mg. ANDA 071431............... Clorazepate Do. Dipotassium Capsules, 15 mg. ANDA 071569............... Danazol Capsules USP, Do. 200 mg. ANDA 071787............... Gen-Xene (clorazepate Alra Laboratories, dipotassium) Inc. Tablets, 3.75 mg. ANDA 071788............... Gen-Xene (clorazepate Do. dipotassium) Tablets, 7.5 mg. ANDA 071789............... Gen-Xene (clorazepate Do. dipotassium) Tablets, 15 mg. ANDA 071955............... Oxazepam Capsules American USP, 10 mg. Therapeutics, Inc. ANDA 071956............... Oxazepam Capsules Do. USP, 15 mg. ANDA 071957............... Oxazepam Capsules Do. USP, 30 mg. ANDA 071962............... Leucovorin Calcium Xanodyne Pharmacal, Tablets, EQ 10 mg Inc. base. ANDA 071965............... Ibu-tab (ibuprofen) Alra Laboratories, Tablets, 800 mg. Inc. ANDA 072022............... Triamterene and American Hydrochlorothiazide Therapeutics, Inc. Tablets, 75 mg/50 mg. ANDA 072129............... Maprotiline HCl Do. Tablets USP, 25 mg. ANDA 072130............... Maprotiline HCl Do. Tablets USP, 50 mg. ANDA 072131............... Maprotiline HCl Do. Tablets USP, 75 mg. ANDA 072190............... Metaproterenol Wockhardt EU Sulfate Inhalation Operations (Swiss) Solution, 5%. AG, c/o Morton Grove Pharmaceuticals, Inc. ANDA 072196............... Milophene (clomiphene Milex Products, Inc., citrate) Tablets, 50 5915 Northwest mg. Highway, Chicago, IL 60631. ANDA 072255............... Microderm Johnson and Johnson (chlorhexidine Medical, Inc., 2500 gluconate) Topical Arbrook Blvd., Solution, 4%. Arlington, TX 76014. [[Page 1164]] ANDA 072292............... Prevacare R Do. (chlorhexidine gluconate) Topical Solution, 0.5%. ANDA 072295............... Microderm Do. (chlorhexidine gluconate) Topical Sponge, 4%. ANDA 072307............... Fenoprofen Calcium American Capsules USP, 200 mg. Therapeutics, Inc. ANDA 072308............... Fenoprofen Calcium Do. Capsules USP, 300 mg. ANDA 072309............... Fenoprofen Calcium Do. Tablets USP, 600 mg. ANDA 072782............... Prazosin HCl Capsules Do. USP, 1 mg. ANDA 072783............... Prazosin HCl Capsules Do. USP, 2 mg. ANDA 072784............... Prazosin HCl Capsules Do. USP, 5 mg. ANDA 073416............... E-Z Scrub Becton Dickinson (chlorhexidine Surgical System, gluconate) Topical 9450 South State Sponge, 4%. St., Sandy, UT 84070. ANDA 073535............... Piroxicam Capsules, Mutual Pharmaceutical 10 mg. Co., Inc., 1100 Orthodox St., Philadelphia, PA 19124. ANDA 074523............... Metromidol Laboratorios (metronidazole) Applicaciones Tablets, 250 mg and Farmaceuticas S.A. 500 mg. de CV, c/o Richard Hamer Association, Inc., P.O. Box 16598, Fort Worth, TX 76162. ANDA 074560............... Flurbiprofen Tablets Theragen, Inc., 10 USP, 100 mg. Lake Dr., East Windsor, NJ 08520. ANDA 074702............... Metaproterenol Wockhardt EU Sulfate Syrup, 10 mg/ Operations (Swiss) 5 mL. AG, c/o Morton Grove Pharmaceuticals, Inc. ANDA 074881............... Iopamidol Injection, Cook Imaging Corp., 41%, 51%, 61%, and 927 South Curry 76%. Pike, P.O. Box 3068, Bloomington, IN 47403. ANDA 074988............... Aspirin, Caffeine, Jerome Stevens and Orphenadrine Pharmaceuticals, Citrate Tablets, 385 Inc. mg/30 mg/25 mg and 770 mg/60 mg/50 mg. ANDA 075181............... Prednisolone Sodium WE Pharmaceuticals, Phosphate Oral Inc. Solution, EQ 5 mg base/5 mL. ANDA 075260............... Tretinoin Topical Wockhardt EU Solution, 0.05%. Operations (Swiss) AG, c/o Morton Grove Pharmaceuticals, Inc. ANDA 075414............... Nifedipine Extended- Martec USA, LLC, 1800 Release Tablets, 90 North Topping Ave., mg. Kansas City, MO 64120. ANDA 075507............... Ipratropium Bromide Pharmascience, Inc., Inhalation Solution, 10 Orchard Pl., 0.02%. Tenafly City, NJ 07670. ANDA 075569............... Thallous Chloride TL Trace Life Sciences, 201 Injection USP, 1 Inc., 2101 Shady millicurie (mCi)/mL. Oaks, Denton, TX 76205. ANDA 075586............... Metaproterenol Wockhardt EU Sulfate Inhalation Operations (Swiss) Solution, 0.4% and AG, c/o Morton Grove 0.6%. Pharmaceuticals, Inc. ANDA 075619............... Minoxidil Extra Avacor Products, LLC, Strength (for Men) 227 East 56th St., Topical Solution, 5%. 3rd Floor, New York, NY 10022. ANDA 075766............... Calcitriol Injection, Fresenius Medical 1 microgram (mcg)/mL Care North America, and 2 mcg/mL. 95 Hayden Ave., Lexington, MA 02421. ANDA 075941............... Strontium Chloride SR- Bio-Nucleonics, Inc., 89 Injection, 1 mCi/ 1600 Market St., mL. Suite 13200, Philadelphia, PA 19103. ANDA 077072............... Ipratropium Bromide Landela Inhalation Solution, Pharmaceutical, 776 0.02%. East Riverside Dr., Suite 150, Eagle, ID 83616. ANDA 077218............... ThyroShield Arco Pharmaceuticals, (potassium iodide) LLC, 7605 Maryland Oral Solution USP, Ave., St. Louis, MO 65 mg/mL. 63105. ANDA 077569............... Albuterol Sulfate Landela Inhalation Solution, Pharmaceutical. EQ 0.083% base. ANDA 080024............... Sulfacel-15 Optopics Laboratories (sulfacetamide Corp., P.O. Box 210, sodium) Ophthalmic Fairton, NJ 08320. Solution, 15%. ANDA 080036............... Sosol (sulfisoxazole) MK Laboratories, Tablets, 500 mg. Inc., 424 Grasmere Ave., Fairfield, CT 06430. ANDA 080366............... Soxazole Alra Laboratories, (sulfisoxazole) Inc. Tablets, 500 mg. ANDA 080380............... Bamate (meprobamate) Do. Tablets, 200 mg and 400 mg. ANDA 080483............... Hi-cor C and M Pharmacal, (hydrocortisone) Inc., 1519 East 8 Cream, 2.5%. Mile Rd., Hazel Park, MI 48030. ANDA 080492............... Reserpine Tablets, Marshall Pharmacal 0.1 mg and 0.25 mg. Corp., 89 Michael St., South Hackensack, NJ 07606. ANDA 080518............... Dimenhydrinate Alra Laboratories, Tablets, 50 mg. Inc. ANDA 080519............... Diphenhydramine HCl Do. Capsules, 25 mg and 50 mg. ANDA 080525............... Reserpine Tablets, MK Laboratories, Inc. 0.1 mg and 0.25 mg. ANDA 080592............... Diphenhydramine HCl Valeant Capsules, 50 mg. Pharmaceuticals International, One Enterprise, Aliso Viejo, CA 92656. ANDA 080660............... Ocusulf Miza Pharmaceuticals (sulfacetamide USA, Inc., c/o sodium) Ophthalmic Optopics Solution, 10% and Laboratories, 40 30%. Main St., P.O. Box 210, Fairton, NJ 08320. ANDA 080714............... Diphenhydramine HCl Alra Laboratories, Oral Solution, 12.5 Inc. mg/5 mL. ANDA 080715............... Dimenhydrinate Oral Do. Solution, 12.5 mg/4 mL. ANDA 080941............... Isoniazid Tablets, MK Laboratories, Inc. 100 mg. ANDA 080970............... Methscopolamine Private Formulations, Bromide Tablets, 2.5 Inc., 460 Plainfield mg. Ave., Edison, NJ 08818. ANDA 081145............... Aspirin and Jerome Stevens Methocarbamol Pharmaceuticals, Tablets, 325 mg/400 Inc. mg. ANDA 083001............... Triamcinolone Lederle Laboratories, Acetonide Aerosol Division of American Foam Emulsion. Cyanamid Co., Pearl River, NY 10965- 1215. ANDA 083087............... Diphenhydramine HCl MK Laboratories, Inc. Capsules, 25 mg and 50 mg. ANDA 083088............... Diphenhydramine HCl Do. Elixir, 12.5 mg/5 mL. ANDA 083264............... Pentobarbital Sodium Valeant Capsules, 100 mg. Pharmaceuticals International. [[Page 1165]] ANDA 083286............... Chlorpheniramine Marshall Pharmacal Maleate Tablets. Corp. ANDA 083315............... Procaine HCl Elkins Sinn Injection, 1% and 2%. Pharmaceutical Co., c/o ESI Lederle, 2 Esterbrook Ln., Cherry Hill, NJ 08003. ANDA 083320............... Acetazolamide Alra Laboratories, Tablets, 250 mg. Inc. ANDA 083389............... Epinephrine and Dell Laboratories, Lidocaine HCl Inc., 668 Front St., Injection, 0.01 mg/ Teaneck, NJ 07666. mL and 1%. ANDA 083390............... Epinephrine and Do. Lidocaine HCl Injection, 0.01 mg/ mL and 2%. ANDA 083457............... Vitamin A Palmitate MK Laboratories, Inc. Capsules, EQ 25,000 units base and EQ 50,000 units base. ANDA 083524............... Butabarbital Sodium Marshall Pharmacal Tablets, 16.2 mg. Corp. ANDA 083525............... Niacin Tablets, 500 MK Laboratories, Inc. mg. ANDA 083526............... Folic Acid Tablets, 1 Do. mg. ANDA 083658............... Promethazine HCl Private Formulations, Tablets, 25 mg. Inc. ANDA 083806............... Dexamethasone Phoenix Laboratories, Tablets, 0.75 mg. Inc., 175 Lauman Ln., East Hicksville, NY 11801. ANDA 083827............... Pramine (imipramine Alra Laboratories, HCl) Tablets, 10 mg, Inc. 25 mg, and 50 mg. ANDA 083858............... Butabarbital Sodium Marshall Pharmacal Tablets, 32.4 mg. Corp. ANDA 083863............... Sulfisoxazole Cream.. Holland Rantos Co., Inc., P.O. Box 385, Piscataway, NJ 08854. ANDA 084185............... Bethanechol Chloride Wendt Laboratories, Tablets, 10 mg. Inc., 200 West Beaver, P.O. Box 128, Belle Plaine, MN 56011. ANDA 084186............... Bethanechol Chloride Do. Tablets, 25 mg. ANDA 084188............... Myotonachol Glenwood, Inc., 83 (bethanechol North Summit St., chloride) Tablets, 5 P.O. Box 518, mg, 10 mg, and 25 mg. Tenafly, NJ 07670. ANDA 084246............... Cortisone Acetate Everylife, 2021 15th Tablets, 25 mg. Ave., West Seattle, WA 98119. ANDA 084439............... Prednisolone Tablets, Do. 1 mg, 2.5 mg, and 5 mg. ANDA 084440............... Prednisone Tablets, 1 Do. mg, 2.5 mg, and 5 mg. ANDA 084494............... Hydrochlorothiazide West-Ward Tablets. Pharmaceutical Corp. ANDA 084590............... Pentobarbital Sodium Anabolic, Inc., 1835 Capsules, 100 mg. East Cheyenne Rd., Colorado Springs, CO 80905. ANDA 084631............... Quinidine Sulfate Sandoz, Inc., 4700 Tablets USP, 200 mg. Eon Dr., Wilson, NC 27893. ANDA 084687............... Niacin Tablets, 500 Zzeon mg. Pharmaceuticals, Ltd., Jamboree at Kevin, Irvine, CA 92705, ANDA 084714............... Hydro-Reserp ABC Holding Corp., (hydrochlorothiazide P.O. Box 307, 70945 and reserpine) Van Dyke Ave., Tablets, 50 mg/0.125 Romeo, MI 48065. mg. ANDA 084729............... Lidocaton Pharmaton, Ltd., c/o (epinephrine and Bass Ullmna and lidocaine HCl) Lustigman, 747 3rd Injection, 0.01 mg/ Ave., New York, NY mL and 2%. 10017. ANDA 084803............... Chlorpromazine HCl Lederle Laboratories, Tablets, 10 mg. Division of American Cyanamid Co., Pearl River, NY 10965- 1215. ANDA 084872............... Meclizine HCl CM Bundy Co., 2055 Tablets, 25 mg. Reading Rd., Cincinnati, OH 45205. ANDA 084902............... Promethacon Polymedica (promethazine HCl) Industries, Inc., 2 Suppository, 50 mg. Constitution Way, Woburn, MA 01801. ANDA 084931............... Methamphetamine HCl Rexar Pharmacal, 396 Tablets, 5 mg and 10 Rockaway Ave., mg. Valley Stream, NY 11581. ANDA 084933............... Diethylstilbestrol West-Ward Tablets, 1 mg. Pharmaceutical Corp. ANDA 084977............... Halothane Inhalation, BH Chemicals, Inc., 99.99%. 500 5th Ave., New York, NY 10036. ANDA 085009............... Lygen Alra Laboratories, (chlordiazepoxide Inc. HCl) Capsules, 10 mg. ANDA 085039............... Folic Acid Tablets Wendt Laboratories, USP, 1 mg. Inc. ANDA 085040............... Isoniazid Tablets Do. USP, 100 mg. ANDA 085041............... Meclizine HCl Do. Tablets, 25 mg. ANDA 085042............... Methocarbamol Tablets Do. USP, 500 mg. ANDA 085044............... Reserpine Tablets Do. USP, 0.25 mg. ANDA 085075............... Aerolate III Fleming and Co. (theophylline) Pharmaceuticals, Extended-Release Inc., 1600 Fenton Capsules, 65 mg. Park Dr., Fenton, MO 63026. Aerolate JR (theophylline) Extended-Release Capsules, 130 mg.. Aerolate SR (theophylline) Extended-Release Capsules, 260 mg.. ANDA 085107............... Lygen Alra Laboratories, (chlordiazepoxide Inc. HCl) Capsules, 5 mg. ANDA 085108............... Lygen Do. (chlordiazepoxide HCl) Capsules, 25 mg. ANDA 085125............... Methyltestosterone Tablicaps, Inc., P.O. Sublingual Tablets, Box 5555, 10 mg. Franklinville, NJ 08322. ANDA 085217............... Acetaminophen and Everylife. Codeine Phosphate Tablets, 325 mg/30 mg. ANDA 085235............... Chlordiazepoxide HCl Abbott Laboratories, Capsules. Pharmaceutical Products Division, 100 Abbott Park Rd., Abbott Park, IL 60064. ANDA 085236............... Chlordiazepoxide HCl Do. Capsules. ANDA 085252............... Meclizine HCl ABC Holding Corp. Tablets, 25 mg. ANDA 085253............... Meclizine HCl Do. Tablets, 12.5 mg. ANDA 085282............... Hydrocortisone Mericon Industries, Lotion, 0.5% and 1%. Inc., 8819 North Pioneer Rd., Peoria, IL 61615. ANDA 085383............... Butabarbital Sodium Wockhardt EU Elixir, 30 mg/5 mL. Operations (Swiss) AG, c/o Morton Grove Pharmaceuticals, Inc. [[Page 1166]] ANDA 085411............... Phentermine HCl ABC Holding Corp. Capsules, 30 mg. ANDA 085511............... Cam-Metrazine Do. (phendimetrazine tartrate) Tablets, 35 mg. ANDA 085512............... Phenazine-35 Do. (phendimetrazine tartrate) Tablets, 35 mg. ANDA 085550............... Butabarbital Sodium CM Bundy Co. Tablets, 30 mg. ANDA 085569............... Chlorothiazide ABC Holding Corp. Tablets, 250 mg. ANDA 085587............... Meclizine Camall Co., Inc., Hydrochloride 60950 Van Dyke Ave., Chewable Tablets. P.O. Box 218, Washington, MI 48094. ANDA 085638............... Codeine, Aspirin, Scherer Laboratories, APAP Formula No. 4 Inc., 2301 Ohio Dr., (codeine phosphate, Suite 234, Plano, TX aspirin, and 75093. acetaminophen) Capsules, 60 mg/180 mg/150 mg. ANDA 085639............... Codeine, Aspirin, Do. APAP Formula No. 3 (codeine phosphate, aspirin, and acetaminophen) Capsules, 30 mg/180 mg/150 mg. ANDA 085640............... Codeine, Aspirin, Do. APAP Formula No. 2 (codeine phosphate, aspirin, and acetaminophen) Capsules, 15 mg/180 mg/150 mg. ANDA 085672............... Hydrochlorothiazide ABC Holding Corp. Tablets, 50 mg. ANDA 085756............... Cam-Metrazine Camall Co., Inc. (phendimetrazine tartrate) Tablets, 35 mg. ANDA 085766............... Atropine Sulfate and Private Formulations, Diphenoxylate HCl Inc. Tablets, 0.025 mg/ 2.5 mg. ANDA 085882............... Duvoid (bethanechol Chartwell RX chloride) Tablets, Sciences, LLC, 77 50 mg. Brenner Dr., Congers, NY 10920. ANDA 085888............... Brompheniramine Leiner Health Maleate Tablets. Products, Inc. ANDA 085891............... Meclizine HCl Anabolic, Inc. Tablets, 25 mg. ANDA 085895............... Secobarbital Sodium Everylife. Capsules, 100 mg. ANDA 086008............... Hydrocortisone and Bioglan Laboratories, Urea Cream, 1%/10%. Ltd., 450 Hilltop Rd., Riegelsville, PA 18077. ANDA 086077............... Nitrofurazone Ambix Laboratories, Ointment, 0.2%. Division of Organics Corp. of America. ANDA 086079............... Hydrocortisone Do. Ointment, 1%. ANDA 086080............... Hydrocortisone Cream, Do. 1%. ANDA 086141............... Tolbutamide Tablets, Alra Laboratories, 500 mg. Inc. ANDA 086260............... Ona-Mast (phentermine MM Mast and Co. HCl) Tablets, 8 mg. ANDA 086262............... Duvoid (bethanechol Chartwell RX chloride) Tablets, Sciences, LLC. 10 mg. ANDA 086263............... Duvoid (bethanechol Do. chloride) Tablets, 25 mg. ANDA 086271............... Hydrocortisone Cream, Ambix Laboratories, 2.5%. Division of Organics Corp. of America. ANDA 086272............... Hydrocortisone Do. Ointment, 2.5%. ANDA 086498............... Amitriptyline HCl Alra Laboratories, Tablets, 10 mg. Inc. ANDA 086499............... Amitriptyline HCl Do. Tablets, 50 mg. ANDA 086500............... Amitriptyline HCl Do. Tablets, 150 mg. ANDA 086501............... Amitriptyline HCl Do. Tablets, 100 mg. ANDA 086502............... Amitriptyline HCl Do. Tablets, 25 mg. ANDA 086503............... Amitriptyline HCl Do. Tablets, 75 mg. ANDA 086511............... Ona-Mast (phentermine MM Mast and Co. HCl) Capsules, 30 mg. ANDA 086516............... Ona-Mast (phentermine Do. HCl) Capsules, 30 mg. ANDA 086550............... X-Trozine Shire Richwood, Inc., (phendimetrazine 7900 Tanners Gate tartrate) Tablets, Dr., Suite 200, 35 mg. Florence, KY 41042. ANDA 086551............... X-Trozine Do. (phendimetrazine tartrate) Tablets, 35 mg. ANDA 086552............... X-Trozine Do. (phendimetrazine tartrate) Tablets, 35 mg. ANDA 086553............... X-Trozine Do. (phendimetrazine tartrate) Tablets, 35 mg. ANDA 086554............... X-Trozine Do. (phendimetrazine tartrate) Tablets, 35 mg. ANDA 086735............... Phentermine HCl Camall Co., Inc. Capsules, 15 mg. ANDA 086748............... Theophylline Elixir, Wockhardt EU 80 mg/15 mL. Operations (Swiss) AG, c/o Morton Grove Pharmaceuticals, Inc. ANDA 086766............... Nitrofurazone Wendt Laboratories, Ointment, 0.2%. Inc. ANDA 087081............... Nitrofurazone Topical Do. Solution, 0.2%. ANDA 087226............... Phentermine HCl Camall Co., Inc. Capsules, 30 mg. ANDA 087371............... X-Trozine L.A. Shire Richwood, Inc. (phendimetrazine tartrate) Extended- Release Capsules, 105 mg. ANDA 087392............... Aminophylline Pharma Serve, Inc., Injection, 25 mg/mL. Subsidiary of Torigian Laboratories, 218-20 98th Ave., Queens Village, NY 11429. ANDA 087394............... X-Trozine Shire Richwood, Inc. (phendimetrazine tartrate) Capsules, 35 mg. ANDA 087442............... Neosar Bedford Laboratories, (cyclophosphamide) Division of Ben for Injection, 100 Venue Laboratories, mg/vial, 200 mg/ Inc., 300 Northfield vial, 500 mg/vial, 1 Rd., Bedford, OH g/vial, and 2 g/vial. 44146. ANDA 087487............... Melfiat-105 Numark Laboratories, (phendimetrazine Inc., 75 Mayfield tartrate) Extended- Ave., Edison, NJ Release Capsules, 08837. 105 mg. ANDA 087636............... Tropicamide Miza Pharmaceuticals Ophthalmic Solution, USA, Inc., c/o 0.5%. Optopics Laboratories. ANDA 087637............... Tropicamide Do. Ophthalmic Solution, 1%. ANDA 087681............... Paracaine Optopics Laboratories (proparacaine HCl) Corp. Ophthalmic Solution, 0.5%. ANDA 087764............... Oby-Trim (phentermine Shire Richwood, Inc. HCl) Capsules, 30 mg. ANDA 087932............... Triamcinolone Ambix Laboratories, Acetonide Cream, Division of Organics 0.025%. Corp. of America. ANDA 088786............... Sodium Polystyrene Wockhardt EU Sulfonate USP Operations (Swiss) Powder, 453.6 g/ AG, c/o Morton Grove bottle. Pharmaceuticals, Inc. [[Page 1167]] ANDA 088897............... Promethazine VC Plain Do. (phenylephrine HCl and promethazine HCl) Syrup, 5 mg/5 mL and 6.25 mg/5 mL. ANDA 089141............... Aerolate Fleming and Co. (theophylline) Oral Pharmaceuticals, Solution, 150 mg/15 Inc. mL. ANDA 089417............... Methocarbamol Tablets American USP, 500 mg. Therapeutics, Inc. ANDA 089418............... Methocarbamol Tablets Do. USP, 750 mg. ANDA 089478............... Acetaminophen and Do. Codeine Phosphate Tablets USP, 300 mg/ 15 mg. ANDA 089479............... Acetaminophen and Do. Codeine Phosphate Tablets USP, 300 mg/ 30 mg. ANDA 089480............... Acetaminophen and Do. Codeine Phosphate Tablets USP, 300 mg/ 60 mg. ANDA 089514............... Trihexyphenidyl HCl Pharmaceutical Elixir, 2 mg/5 mL. Ventures, Ltd., P.O. Box D3700, Pomona, NY 10970. ANDA 089726............... Prednisone Oral Wockhardt EU Solution, 5 mg/5 mL. Operations (Swiss) AG, c/o Morton Grove Pharmaceuticals, Inc. ANDA 204472............... Fludeoxyglucose F-18 MIPS Cyclotron and Injection USP, 20- Radiochemistry 300 mCi/mL. Facility, 1201 Welch Rd., Rm. PS049, Stanford, CA 94305. ANDA 204517............... Sodium Fluoride F-18 Do. Injection, 10-200 mCi/mL. ANDA 204535............... Ammonia N-13 Do. Injection USP, 3.75- 37.5 mCi/mL. ------------------------------------------------------------------------ Therefore, under Sec. Sec. 314.150(b)(1) and 314.200 (21 CFR 314.150(b)(1) and 314.200), notice is given to the holders of the approved ANDAs listed in the table and to all other interested persons that the Director of CDER proposes to issue an order under section 505(e) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(e)) withdrawing approval of the ANDAs and all amendments and supplements to them on the grounds that the ANDA holders have failed to submit reports required under Sec. Sec. 314.81 and 314.98. In accordance with section 505 of the FD&C Act and part 314 (21 CFR part 314), the ANDA holders are hereby provided an opportunity for a hearing to show why the applications listed previously should not be withdrawn and an opportunity to raise, for an administrative determination, all issues relating to the legal status of the drug products covered by these ANDAs. An ANDA holder who decides to seek a hearing must file the following: (1) A written notice of participation and request for a hearing (see DATES and ADDRESSES) and (2) the data, information, and analyses relied on to demonstrate that there is a genuine and substantial issue of fact that requires a hearing (see DATES and ADDRESSES). Any other interested person may also submit comments on this notice. The procedures and requirements governing this notice of opportunity for a hearing, the notice of participation and request for a hearing; the information and analyses to justify a hearing, other comments, and a grant or denial of a hearing are contained in Sec. 314.200 and in 21 CFR part 12. The failure of an ANDA holder to file a timely written notice of participation and request for a hearing, as required by Sec. 314.200, constitutes an election by that ANDA holder not to avail itself of the opportunity for a hearing concerning CDER's proposal to withdraw approval of the ANDAs and constitutes a waiver of any contentions concerning the legal status of the drug products. FDA will then withdraw approval of the ANDAs, and the drug products may not thereafter be lawfully introduced or delivered for introduction into interstate commerce. Any new drug product introduced or delivered for introduction into interstate commerce without an approved ANDA is subject to regulatory action at any time. A request for a hearing may not rest upon mere allegations or denials but must present specific facts showing that there is a genuine and substantial issue of fact that requires a hearing. If a request for a hearing is not complete or is not supported, the Commissioner of Food and Drugs will enter summary judgment against the person who requests the hearing, making findings and conclusions, and denying a hearing. All submissions under this notice of opportunity for a hearing must be filed in four copies. Except for data and information prohibited from public disclosure under 21 U.S.C. 331(j) or 18 U.S.C. 1905, the submissions may be seen at the Dockets Management Staff (see ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov. This notice is issued under section 505(e) of the FD&C Act and under authority delegated to the Director of CDER by the Commissioner of Food and Drugs. Dated: January 3, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020-00120 Filed 1-8-20; 8:45 am] BILLING CODE 4164-01-P