Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 072539
Company: WATSON LABS
Company: WATSON LABS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE | 10MG;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 |
---|---|---|---|---|---|---|---|
02/15/1989 | 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 |
---|---|---|---|---|---|
04/11/1996 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
11/04/1993 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
05/31/1989 | SUPPL-1 | Labeling |
Label is not available on this site. |