Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 216653
Company: SOMERSET THERAPS LLC
Company: SOMERSET THERAPS LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TIMOLOL MALEATE | TIMOLOL MALEATE | EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | AT2 | 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 |
|---|---|---|---|---|---|---|---|
| 07/03/2024 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
TIMOLOL MALEATE
SOLUTION/DROPS;OPHTHALMIC; EQ 0.5% BASE
TE Code = AT2
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ISTALOL | TIMOLOL MALEATE | EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | Yes | AT2 | 021516 | BAUSCH AND LOMB |
| TIMOLOL MALEATE | TIMOLOL MALEATE | EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT2 | 204936 | APOTEX |
| TIMOLOL MALEATE | TIMOLOL MALEATE | EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT2 | 216653 | SOMERSET THERAPS LLC |