Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074479
Company: WATSON LABS
Company: WATSON LABS
| 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 |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 01/21/1997 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/97/074479ap.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/21/2001 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 04/12/2001 | SUPPL-8 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 09/19/2000 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 03/21/2000 | SUPPL-6 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 05/21/1999 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/14/1998 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/21/1998 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/20/1998 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |