Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019921
Company: ALLERGAN
Company: ALLERGAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| OCUFLOX | OFLOXACIN | 0.3% | SOLUTION/DROPS;OPHTHALMIC | Prescription | AT | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 07/30/1993 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/16/2016 | SUPPL-21 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019921s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019921Orig1s021ltr.pdf | |
| 02/15/2002 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/04/2001 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/18/2001 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/12/2001 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/19/2001 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/02/2000 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/09/1999 | SUPPL-8 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019921_S008_Ocuflox_Approval_Package.pdf |
| 03/15/1999 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/04/1998 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/19/1998 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/18/1997 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/22/1996 | SUPPL-3 | Efficacy-New Indication |
Label is not available on this site. |
||
| 06/12/1995 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/03/1995 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/16/2016 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019921s021lbl.pdf |
OCUFLOX
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 |