Drugs@FDA: FDA-Approved Drugs
Company: TEVA
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 |
---|---|---|---|---|---|
07/13/2015 | SUPPL-40 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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07/13/2015 | SUPPL-39 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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07/13/2015 | SUPPL-38 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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06/28/2008 | SUPPL-31 | Labeling |
Label is not available on this site. |
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03/11/2009 | SUPPL-30 | Labeling |
Label is not available on this site. |
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02/17/2006 | SUPPL-26 | Labeling |
Label is not available on this site. |
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10/22/2001 | SUPPL-18 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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10/22/2001 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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12/13/2000 | SUPPL-16 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
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08/28/2000 | SUPPL-14 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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12/02/1999 | SUPPL-13 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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12/02/1999 | SUPPL-12 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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02/12/1999 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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02/12/1999 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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08/16/1996 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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10/29/1996 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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03/13/1996 | SUPPL-3 | Labeling |
Label is not available on this site. |
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01/27/1995 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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10/21/1994 | 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 |