Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204884
Company: BAUSCH AND LOMB
Company: BAUSCH AND LOMB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BRINZOLAMIDE | BRINZOLAMIDE | 1% | SUSPENSION/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 |
---|---|---|---|---|---|---|---|
08/18/2021 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
BRINZOLAMIDE
SUSPENSION/DROPS;OPHTHALMIC; 1%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
AZOPT | BRINZOLAMIDE | 1% | SUSPENSION/DROPS;OPHTHALMIC | Prescription | Yes | AB | 020816 | SANDOZ |
BRINZOLAMIDE | BRINZOLAMIDE | 1% | SUSPENSION/DROPS;OPHTHALMIC | Prescription | No | AB | 204884 | BAUSCH AND LOMB |
BRINZOLAMIDE | BRINZOLAMIDE | 1% | SUSPENSION/DROPS;OPHTHALMIC | Prescription | No | AB | 211914 | PADAGIS US |
BRINZOLAMIDE | BRINZOLAMIDE | 1% | SUSPENSION/DROPS;OPHTHALMIC | Prescription | No | AB | 209406 | WATSON LABS INC |