Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 211525
Company: AMNEAL
Company: AMNEAL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OFLOXACIN | OFLOXACIN | 0.3% | SOLUTION/DROPS;OTIC | 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 |
---|---|---|---|---|---|---|---|
08/30/2019 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
OFLOXACIN
SOLUTION/DROPS;OTIC; 0.3%
TE Code = AT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
OFLOXACIN | OFLOXACIN | 0.3% | SOLUTION/DROPS;OTIC | Prescription | No | AT | 211525 | AMNEAL |
OFLOXACIN | OFLOXACIN | 0.3% | SOLUTION/DROPS;OTIC | Prescription | No | AT | 076527 | APOTEX INC |
OFLOXACIN | OFLOXACIN | 0.3% | SOLUTION/DROPS;OTIC | Prescription | No | AT | 076128 | BAUSCH AND LOMB |
OFLOXACIN | OFLOXACIN | 0.3% | SOLUTION/DROPS;OTIC | Prescription | No | AT | 217903 | CAPLIN |
OFLOXACIN | OFLOXACIN | 0.3% | SOLUTION/DROPS;OTIC | Prescription | No | AT | 216130 | MANKIND PHARMA |