Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075927
Company: AMNEAL PHARMS NY
Company: AMNEAL PHARMS NY
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 |
---|---|---|---|---|---|---|---|
12/18/2001 | 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 |
---|---|---|---|---|---|
11/22/2019 | SUPPL-31 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
11/22/2019 | SUPPL-27 | Labeling-Package Insert, Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
11/22/2019 | SUPPL-25 | Labeling-Package Insert |
Label is not available on this site. |
||
11/02/2014 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
10/16/2007 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
05/19/2006 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
11/20/2002 | SUPPL-1 | Manufacturing (CMC)-Control |
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 |