Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074215
Company: MYLAN
Company: MYLAN
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 |
---|---|---|---|---|---|---|---|
01/27/1994 | 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 |
---|---|---|---|---|---|
12/31/2019 | SUPPL-24 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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09/27/2011 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
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06/01/2012 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
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06/28/2008 | SUPPL-18 | Labeling |
Label is not available on this site. |
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04/03/2002 | SUPPL-6 | Labeling |
Label is not available on this site. |
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10/18/2000 | SUPPL-5 | Labeling |
Label is not available on this site. |
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05/06/1998 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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02/03/1998 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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02/05/1998 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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11/07/1997 | SUPPL-1 | Labeling |
Label is not available on this site. |