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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019921
Company: ALLERGAN

Products on NDA 019921

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019921

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.

Labels for NDA 019921

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

Therapeutic Equivalents for NDA 019921

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	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	218557	MICRO LABS
OFLOXACIN	OFLOXACIN	0.3%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	076407	SENTISS
OFLOXACIN	OFLOXACIN	0.3%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	213597	SOMERSET

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