Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074211
Company: ROXANE
Company: ROXANE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NAPROXEN | NAPROXEN | 250MG | TABLET;ORAL | Discontinued | None | No | No |
NAPROXEN | NAPROXEN | 375MG | TABLET;ORAL | Discontinued | None | No | No |
NAPROXEN | NAPROXEN | 500MG | TABLET;ORAL | Discontinued | None | 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 |
---|---|---|---|---|---|---|---|
02/28/1994 | 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 |
---|---|---|---|---|---|
03/27/1997 | SUPPL-5 | Labeling |
Label is not available on this site. |
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08/28/1996 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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12/05/1997 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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02/07/1996 | SUPPL-2 | Labeling |
Label is not available on this site. |
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01/13/1995 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |