[Federal Register Volume 84, Number 231 (Monday, December 2, 2019)]
[Notices]
[Page 65986]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-25946]
[[Page 65986]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-4590]
Morton Grove Pharmaceuticals, Inc., et al.; Withdrawal of
Approval of 21 Abbreviated New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of 21 abbreviated new drug applications (ANDAs)
from multiple applicants. The applicants notified the Agency in writing
that the drug products were no longer marketed and requested that the
approval of the applications be withdrawn.
DATES: Approval is withdrawn as of January 2, 2020.
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-
402-6980, [email protected]. SUPPLEMENTARY INFORMATION: The
applicants listed in the table have informed FDA that these drug
products are no longer marketed and have requested that FDA withdraw
approval of the applications under the process described in Sec.
314.150(c) (21CFR 314.150(c)). The applicants have also, by their
requests, waived their opportunity for a hearing. Withdrawal of
approval of an application or abbreviated application under Sec.
314.150(c) is without prejudice to refiling.
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Application No. Drug Applicant
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ANDA 040759.................. Phenytoin Sodium Morton Grove
Capsules, Pharmaceuticals,
30milligrams (mg) Inc., 6451 Main
(Extended). St., Morton Grove,
IL 60053.
ANDA 062349.................. Nystatin Oral G&W Laboratories,
Suspension, 100,000 Inc., 301 Helen
units/milliters St., South
(mL). Plainfield, NJ
07080.
ANDA 062483.................. Griseofulvin V Valeant
(griseofulvin Pharmaceuticals
microsize) Oral North America,
Suspension, 125 mg/ LLC, 400 Somerset
5 mL. Corporate Blvd.,
Bridgewater, NJ
08807.
ANDA 063264.................. Amikacin Sulfate Hospira, Inc., 275
Injection USP, North Field Dr.,
Equivalent to (EQ) Bldg. H1, Lake
250 mg base/mL. Forest, IL 60045.
ANDA 072655.................. Amantadine G&W Laboratories,
Hydrochloride (HCl) Inc.
Syrup USP, 50 mg/5
mL.
ANDA 074176.................. Cimetidine HCl Oral Do.
Solution, EQ 300 mg
base/5 mL.
ANDA 075366.................. Sotalol HCl Tablets Upsher-Smith
USP 80 mg, 120 mg, Laboratories, LLC,
160 mg, and 240 mg. 6701 Evenstad Dr.,
Maple Grove, MN
55369.
ANDA 075887.................. Fluvoxamine Maleate Do.
Tablets, 25 mg, 50
mg, and 100 mg.
ANDA 076709.................. Fentanyl Extended- Actavis
Release Film, 25 Laboratories UT,
micrograms (mcg)/ Inc., Subsidiary
hr, 50 mcg/hr, 75 of Teva
mcg/hr, 100 mcg/hr. Pharmaceuticals
USA, Inc, 577
Chipeta Way, Salt
Lake City, UT
84108.
ANDA 076841.................. Mesalamine Enema, 4 G&W Laboratories,
grams (gm)/60 mL. Inc.
ANDA 077062.................. Fentanyl Extended- Mayne Pharma LLC,
Release Film, 25 1240 Sugg Parkway,
mcg/hr, 50 mcg/hr, Greenville, NC
75 mcg/hr, and 100 27834.
mcg/hr.
ANDA 078426.................. Zolpidem Tartrate Morton Grove
Tablets, 5 mg and Pharmaceuticals
10 mg. Inc.
ANDA 078653.................. Ranitidine HCl Do.
Tablets USP, EQ 150
mg base.
ANDA 078701.................. Ranitidine HCl Do.
Tablets USP, EQ 150
mg base and EQ 300
mg base.
ANDA 078884.................. Ranitidine HCl Do.
Tablets USP, EQ 75
mg base.
ANDA 087811.................. Phrenilin Bausch Health US,
(acetaminophen and LLC.
butalbital)
Tablets, 325 mg/50
mg.
ANDA 088761.................. Prometh VC Plain G&W Laboratories,
(promethazine HCl Inc.
and phenylephrine
HCl) Syrup, 5 mg/
5mL, and 6.25 mg/5
mL.
ANDA 088762.................. Prometh w/ Do.
Dextromethorphan
(promethazine HCl
and
dextromethorphan
hydrobromide)
Syrup, 6.25 mg/5 mL
and 15 mg/5 mL.
ANDA 090786.................. Carbidopa, Morton Grove
Entacapone, and Pharmaceuticals
Levodopa Tablets, Inc.
12.5 mg/200 mg/50
mg.
ANDA 091267.................. Donepezil HCl Do.
Tablets, 5 mg and
10 mg.
ANDA 201947.................. Morphine Sulfate VistaPharm, Inc.,
Oral Solution, 10 7265 Ulmerton Rd.,
mg/5 mL and 20 mg/5 Largo, FL 33771.
mL.
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Do = Ditto.
Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of
January 2, 2020. Approval of each entire application is withdrawn,
including any strengths or products inadvertently missing from the
table. Introduction or delivery for introduction into interstate
commerce of products without approved new drug applications violates
section 301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 331(a) and (d)). Drug products that are listed in the table that
are in inventory on January 2, 2020 may continue to be dispensed until
the inventories have been depleted or the drug products have reached
their expiration dates or otherwise become violative, whichever occurs
first.
Dated: November 25, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-25946 Filed 11-29-19; 8:45 am]
BILLING CODE 4164-01-P