Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074111
Company: IVAX SUB TEVA PHARMS
Company: IVAX SUB TEVA PHARMS
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 |
---|---|---|---|---|---|---|---|
02/28/1995 | 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 |
---|---|---|---|---|---|
07/29/2002 | SUPPL-3 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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01/28/2000 | SUPPL-2 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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12/02/1996 | SUPPL-1 | Labeling |
Label is not available on this site. |