Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076527
Company: APOTEX INC
Company: APOTEX INC
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 |
---|---|---|---|---|---|---|---|
09/28/2007 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/076527.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/06/2008 | SUPPL-7 | Labeling |
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 |