Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019921
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 076407 AKORN
OFLOXACIN OFLOXACIN 0.3% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 202692 ALTAIRE PHARMS INC
OFLOXACIN OFLOXACIN 0.3% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 076830 ALVOGEN
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 078559 FDC LTD
OFLOXACIN OFLOXACIN 0.3% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 076615 HI TECH PHARMA

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