Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202903
Company: LUPIN LTD
Company: LUPIN LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BROMFENAC SODIUM | BROMFENAC SODIUM | EQ 0.09% ACID | 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 |
---|---|---|---|---|---|---|---|
08/15/2023 | ORIG-1 | Approval |
Label is not available on this site. |
BROMFENAC SODIUM
SOLUTION/DROPS;OPHTHALMIC; EQ 0.09% ACID
TE Code = AT2
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BROMFENAC SODIUM | BROMFENAC SODIUM | EQ 0.09% ACID | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT2 | 210560 | ALEMBIC |
BROMFENAC SODIUM | BROMFENAC SODIUM | EQ 0.09% ACID | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT2 | 204813 | EUGIA PHARMA |
BROMFENAC SODIUM | BROMFENAC SODIUM | EQ 0.09% ACID | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT2 | 211029 | GLAND PHARMA LTD |
BROMFENAC SODIUM | BROMFENAC SODIUM | EQ 0.09% ACID | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT2 | 202903 | LUPIN LTD |
BROMFENAC SODIUM | BROMFENAC SODIUM | EQ 0.09% ACID | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT2 | 203395 | SENTISS |