Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 217288
Company: AMNEAL
Company: AMNEAL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BRIMONIDINE TARTRATE AND TIMOLOL MALEATE | BRIMONIDINE TARTRATE; TIMOLOL MALEATE | 0.2%;EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | 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 |
|---|---|---|---|---|---|---|---|
| 12/30/2024 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |