Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074085
Company: ANI PHARMS
Company: ANI PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ALPRAZOLAM | ALPRAZOLAM | 0.25MG | TABLET;ORAL | Discontinued | None | No | No |
ALPRAZOLAM | ALPRAZOLAM | 0.5MG | TABLET;ORAL | Discontinued | None | No | No |
ALPRAZOLAM | ALPRAZOLAM | 1MG | TABLET;ORAL | Discontinued | None | No | No |
ALPRAZOLAM | ALPRAZOLAM | 2MG | 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 |
---|---|---|---|---|---|---|---|
02/16/1994 | 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 |
---|---|---|---|---|---|
02/10/1998 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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03/06/1997 | SUPPL-6 | Labeling |
Label is not available on this site. |
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01/23/1996 | SUPPL-4 | Labeling |
Label is not available on this site. |
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01/23/1996 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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02/26/1996 | SUPPL-2 | Labeling |
Label is not available on this site. |
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02/26/1996 | SUPPL-1 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |