Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 215550
Company: LUPIN LTD
Company: LUPIN LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LOTEPREDNOL ETABONATE | LOTEPREDNOL ETABONATE | 0.2% | 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 |
---|---|---|---|---|---|---|---|
12/26/2023 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
LOTEPREDNOL ETABONATE
SUSPENSION/DROPS;OPHTHALMIC; 0.2%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ALREX | LOTEPREDNOL ETABONATE | 0.2% | SUSPENSION/DROPS;OPHTHALMIC | Prescription | Yes | AB | 020803 | BAUSCH AND LOMB |
LOTEPREDNOL ETABONATE | LOTEPREDNOL ETABONATE | 0.2% | SUSPENSION/DROPS;OPHTHALMIC | Prescription | No | AB | 215550 | LUPIN LTD |
LOTEPREDNOL ETABONATE | LOTEPREDNOL ETABONATE | 0.2% | SUSPENSION/DROPS;OPHTHALMIC | Prescription | No | AB | 215933 | SENTISS |