Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074046
Company: MYLAN PHARMS INC
Company: MYLAN PHARMS INC
| 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 |
|---|---|---|---|---|---|---|---|
| 10/19/1993 | 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 |
|---|---|---|---|---|---|
| 05/07/2007 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 11/19/2001 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 12/22/2000 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 05/07/1997 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 05/07/1997 | SUPPL-1 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |