Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 072917
Company: ANI PHARMS
Company: ANI PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TIMOLOL MALEATE | TIMOLOL MALEATE | 5MG | 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 |
---|---|---|---|---|---|---|---|
07/31/1991 | 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 |
---|---|---|---|---|---|
05/20/1996 | SUPPL-3 | Labeling |
Label is not available on this site. |
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06/02/1993 | SUPPL-2 | Labeling |
Label is not available on this site. |
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02/10/1992 | SUPPL-1 | Bioequivalence |
Label is not available on this site. |