Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 216343
Company: AMNEAL
Company: AMNEAL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TIMOLOL MALEATE | TIMOLOL MALEATE | EQ 0.25% BASE | SOLUTION, GEL FORMING/DROPS;OPHTHALMIC | Discontinued | None | No | No |
| TIMOLOL MALEATE | TIMOLOL MALEATE | EQ 0.5% BASE | SOLUTION, GEL FORMING/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 |
|---|---|---|---|---|---|---|---|
| 05/23/2024 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/216343Orig1s000ltr.pdf |