Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076513
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;OPHTHALMIC | 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 |
---|---|---|---|---|---|---|---|
05/14/2004 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76513ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/13/2019 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
07/20/2020 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
||
08/06/2008 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
02/26/2014 | SUPPL-10 | Labeling |
Label is not available on this site. |
OFLOXACIN
SOLUTION/DROPS;OPHTHALMIC; 0.3%
TE Code = AT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
OCUFLOX | OFLOXACIN | 0.3% | SOLUTION/DROPS;OPHTHALMIC | Prescription | Yes | AT | 019921 | ALLERGAN |
OFLOXACIN | OFLOXACIN | 0.3% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 202692 | ALTAIRE PHARMS INC |
OFLOXACIN | OFLOXACIN | 0.3% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 211524 | AMNEAL |
OFLOXACIN | OFLOXACIN | 0.3% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 076513 | APOTEX INC |
OFLOXACIN | OFLOXACIN | 0.3% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 076622 | BAUSCH AND LOMB |
OFLOXACIN | OFLOXACIN | 0.3% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 217904 | CAPLIN |
OFLOXACIN | OFLOXACIN | 0.3% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 078559 | FDC LTD |
OFLOXACIN | OFLOXACIN | 0.3% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 215886 | MANKIND PHARMA |
OFLOXACIN | OFLOXACIN | 0.3% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 076407 | SENTISS |
OFLOXACIN | OFLOXACIN | 0.3% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 213597 | SOMERSET |