Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 217846
Company: MICRO LABS
Company: MICRO LABS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BRIMONIDINE TARTRATE | BRIMONIDINE TARTRATE | 0.2% | SOLUTION/DROPS;OPHTHALMIC | Prescription | AT | 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 |
---|---|---|---|---|---|---|---|
11/22/2023 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
BRIMONIDINE TARTRATE
SOLUTION/DROPS;OPHTHALMIC; 0.2%
TE Code = AT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BRIMONIDINE TARTRATE | BRIMONIDINE TARTRATE | 0.2% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 076260 | BAUSCH AND LOMB |
BRIMONIDINE TARTRATE | BRIMONIDINE TARTRATE | 0.2% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 091691 | INDOCO |
BRIMONIDINE TARTRATE | BRIMONIDINE TARTRATE | 0.2% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 217846 | MICRO LABS |
BRIMONIDINE TARTRATE | BRIMONIDINE TARTRATE | 0.2% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 076439 | RISING |
BRIMONIDINE TARTRATE | BRIMONIDINE TARTRATE | 0.2% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 076254 | SANDOZ |
BRIMONIDINE TARTRATE | BRIMONIDINE TARTRATE | 0.2% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 078075 | SANDOZ |
BRIMONIDINE TARTRATE | BRIMONIDINE TARTRATE | 0.2% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 208992 | SOMERSET THERAPS LLC |