Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091086
Company: SENTISS
Company: SENTISS
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 | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
10/31/2022 | ORIG-1 | Approval |
Label is not available on this site. |
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE
SOLUTION/DROPS;OPHTHALMIC; 0.2%;EQ 0.5% BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE | BRIMONIDINE TARTRATE; TIMOLOL MALEATE | 0.2%;EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AB | 215230 | ALEMBIC |
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE | BRIMONIDINE TARTRATE; TIMOLOL MALEATE | 0.2%;EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AB | 091442 | APOTEX |
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE | BRIMONIDINE TARTRATE; TIMOLOL MALEATE | 0.2%;EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AB | 201949 | FLORIDA |
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE | BRIMONIDINE TARTRATE; TIMOLOL MALEATE | 0.2%;EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AB | 214987 | GLENMARK PHARMS LTD |
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE | BRIMONIDINE TARTRATE; TIMOLOL MALEATE | 0.2%;EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AB | 091087 | SANDOZ |
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE | BRIMONIDINE TARTRATE; TIMOLOL MALEATE | 0.2%;EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AB | 091086 | SENTISS |
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE | BRIMONIDINE TARTRATE; TIMOLOL MALEATE | 0.2%;EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AB | 216114 | SOMERSET |
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE | BRIMONIDINE TARTRATE; TIMOLOL MALEATE | 0.2%;EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AB | 215598 | UPSHER SMITH LABS |
COMBIGAN | BRIMONIDINE TARTRATE; TIMOLOL MALEATE | 0.2%;EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | Yes | AB | 021398 | ABBVIE |