Drugs@FDA: FDA-Approved Drugs
Company: KEY THERAP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NALFON | FENOPROFEN CALCIUM | EQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | No | No |
NALFON | FENOPROFEN CALCIUM | EQ 200MG BASE | CAPSULE;ORAL | Prescription | AB | Yes | No |
NALFON | FENOPROFEN CALCIUM | EQ 400MG BASE | CAPSULE;ORAL | Prescription | AB | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
03/16/1976 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/28/2021 | SUPPL-51 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017604s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/017604Orig1s051ltr.pdf | |
05/09/2016 | SUPPL-46 | Labeling-Medication Guide, Labeling-Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017604s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017604Orig1s046ltr.pdf | |
07/21/2009 | SUPPL-43 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017604s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017604s043ltr.pdf | |
08/07/2007 | SUPPL-41 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017604s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017604s041ltr.pdf | |
01/18/2006 | SUPPL-40 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017604s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017604s040ltr.pdf | |
08/21/2001 | SUPPL-38 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
11/24/1999 | SUPPL-37 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
09/30/1998 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/02/1998 | SUPPL-33 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
12/22/1997 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
01/22/1996 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/25/1994 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/29/1995 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
07/15/1987 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/23/1987 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/09/1986 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
12/11/1987 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/31/1983 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
07/29/1983 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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08/09/1983 | SUPPL-16 | Labeling |
Label is not available on this site. |
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07/14/1981 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
05/06/1980 | SUPPL-14 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
08/09/1983 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
10/15/1980 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/15/1980 | SUPPL-9 | Efficacy |
Label is not available on this site. |
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10/24/1978 | SUPPL-7 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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04/01/1977 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
09/23/1976 | SUPPL-3 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
04/28/2021 | SUPPL-51 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017604s051lbl.pdf | |
04/28/2021 | SUPPL-51 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017604s051lbl.pdf | |
05/09/2016 | SUPPL-46 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017604s046lbl.pdf | |
05/09/2016 | SUPPL-46 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017604s046lbl.pdf | |
05/09/2016 | SUPPL-46 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017604s046lbl.pdf | |
07/21/2009 | SUPPL-43 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017604s043lbl.pdf | |
07/21/2009 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017604s043lbl.pdf | |
08/07/2007 | SUPPL-41 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017604s041lbl.pdf | |
01/18/2006 | SUPPL-40 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017604s040lbl.pdf |
NALFON
CAPSULE;ORAL; EQ 200MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FENOPROFEN CALCIUM | FENOPROFEN CALCIUM | EQ 200MG BASE | CAPSULE;ORAL | Prescription | No | AB | 215548 | MISEMER |
NALFON | FENOPROFEN CALCIUM | EQ 200MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 017604 | KEY THERAP |
CAPSULE;ORAL; EQ 400MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FENOPROFEN CALCIUM | FENOPROFEN CALCIUM | EQ 400MG BASE | CAPSULE;ORAL | Prescription | No | AB | 215548 | MISEMER |
FENOPROFEN CALCIUM | FENOPROFEN CALCIUM | EQ 400MG BASE | CAPSULE;ORAL | Prescription | No | AB | 214475 | RISING |
NALFON | FENOPROFEN CALCIUM | EQ 400MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 017604 | KEY THERAP |