Drugs@FDA: FDA-Approved Drugs
Company: GRANULES
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NAPROXEN | NAPROXEN | 250MG | TABLET;ORAL | Prescription | AB | No | No |
| NAPROXEN | NAPROXEN | 375MG | TABLET;ORAL | Prescription | AB | No | No |
| NAPROXEN | NAPROXEN | 500MG | TABLET;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/21/1993 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/11/2022 | SUPPL-42 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/11/2022 | SUPPL-41 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/11/2022 | SUPPL-40 | Labeling-Patient Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 03/11/2022 | SUPPL-38 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/11/2022 | SUPPL-37 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/29/2008 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 04/29/2008 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 11/28/2007 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 07/15/2007 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 03/25/2002 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/19/2002 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/22/2001 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/05/2001 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/05/2001 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/13/2000 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/05/1999 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/13/2000 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/13/2000 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/13/2000 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/17/1998 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/14/1998 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/17/2000 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 08/17/2000 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/03/1997 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/22/1997 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/01/1995 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/31/1995 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/05/1995 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
NAPROXEN
TABLET;ORAL; 250MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| NAPROXEN | NAPROXEN | 250MG | TABLET;ORAL | Prescription | No | AB | 075927 | AMNEAL PHARMS NY |
| NAPROXEN | NAPROXEN | 250MG | TABLET;ORAL | Prescription | No | AB | 200429 | AUROBINDO PHARMA |
| NAPROXEN | NAPROXEN | 250MG | TABLET;ORAL | Prescription | No | AB | 078250 | GLENMARK PHARMS LTD |
| NAPROXEN | NAPROXEN | 250MG | TABLET;ORAL | Prescription | No | AB | 074140 | GRANULES |
| NAPROXEN | NAPROXEN | 250MG | TABLET;ORAL | Prescription | No | AB | 091416 | MARKSANS PHARMA |
| NAPROXEN | NAPROXEN | 250MG | TABLET;ORAL | Prescription | No | AB | 212517 | SCIEGEN PHARMS INC |
| NAPROXEN | NAPROXEN | 250MG | TABLET;ORAL | Prescription | No | AB | 074201 | TEVA |
| NAPROXEN | NAPROXEN | 250MG | TABLET;ORAL | Prescription | No | AB | 078620 | ZYDUS PHARMS USA |
TABLET;ORAL; 375MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| NAPROXEN | NAPROXEN | 375MG | TABLET;ORAL | Prescription | No | AB | 075927 | AMNEAL PHARMS NY |
| NAPROXEN | NAPROXEN | 375MG | TABLET;ORAL | Prescription | No | AB | 200429 | AUROBINDO PHARMA |
| NAPROXEN | NAPROXEN | 375MG | TABLET;ORAL | Prescription | No | AB | 078250 | GLENMARK PHARMS LTD |
| NAPROXEN | NAPROXEN | 375MG | TABLET;ORAL | Prescription | No | AB | 074140 | GRANULES |
| NAPROXEN | NAPROXEN | 375MG | TABLET;ORAL | Prescription | No | AB | 091416 | MARKSANS PHARMA |
| NAPROXEN | NAPROXEN | 375MG | TABLET;ORAL | Prescription | No | AB | 212517 | SCIEGEN PHARMS INC |
| NAPROXEN | NAPROXEN | 375MG | TABLET;ORAL | Prescription | No | AB | 074201 | TEVA |
| NAPROXEN | NAPROXEN | 375MG | TABLET;ORAL | Prescription | No | AB | 078620 | ZYDUS PHARMS USA |
TABLET;ORAL; 500MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| NAPROSYN | NAPROXEN | 500MG | TABLET;ORAL | Prescription | Yes | AB | 017581 | ATNAHS PHARMA US |
| NAPROXEN | NAPROXEN | 500MG | TABLET;ORAL | Prescription | No | AB | 075927 | AMNEAL PHARMS NY |
| NAPROXEN | NAPROXEN | 500MG | TABLET;ORAL | Prescription | No | AB | 200429 | AUROBINDO PHARMA |
| NAPROXEN | NAPROXEN | 500MG | TABLET;ORAL | Prescription | No | AB | 078250 | GLENMARK PHARMS LTD |
| NAPROXEN | NAPROXEN | 500MG | TABLET;ORAL | Prescription | No | AB | 074140 | GRANULES |
| NAPROXEN | NAPROXEN | 500MG | TABLET;ORAL | Prescription | No | AB | 091416 | MARKSANS PHARMA |
| NAPROXEN | NAPROXEN | 500MG | TABLET;ORAL | Prescription | No | AB | 212517 | SCIEGEN PHARMS INC |
| NAPROXEN | NAPROXEN | 500MG | TABLET;ORAL | Prescription | No | AB | 074201 | TEVA |
| NAPROXEN | NAPROXEN | 500MG | TABLET;ORAL | Prescription | No | AB | 078620 | ZYDUS PHARMS USA |