Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078480
Company: APOTEX
Company: APOTEX
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BRIMONIDINE TARTRATE | BRIMONIDINE TARTRATE | 0.1% | 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 |
---|---|---|---|---|---|---|---|
12/21/2022 | ORIG-1 | Approval |
Label is not available on this site. |
BRIMONIDINE TARTRATE
SOLUTION/DROPS;OPHTHALMIC; 0.1%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ALPHAGAN P | BRIMONIDINE TARTRATE | 0.1% | SOLUTION/DROPS;OPHTHALMIC | Prescription | Yes | AB | 021770 | ABBVIE |
BRIMONIDINE TARTRATE | BRIMONIDINE TARTRATE | 0.1% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AB | 216909 | ALEMBIC |
BRIMONIDINE TARTRATE | BRIMONIDINE TARTRATE | 0.1% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AB | 078480 | APOTEX |
BRIMONIDINE TARTRATE | BRIMONIDINE TARTRATE | 0.1% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AB | 203172 | SANDOZ |