Details for New Drug Application (NDA): 019921

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NDA 019921 describes OCUFLOX, which is a drug marketed by Allergan and is included in one NDA. It is available from one supplier. Additional details are available on the OCUFLOX profile page.

The generic ingredient in OCUFLOX is ofloxacin. There are seventy-eight drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the ofloxacin profile page.

Summary for 019921

Tradename:	OCUFLOX
Applicant:	Allergan
Ingredient:	ofloxacin
Patents:	0

Pharmacology for NDA: 019921

Medical Subject Heading (MeSH) Categories for 019921

Anti-Bacterial Agents
Anti-Infective Agents, Urinary
Cytochrome P-450 CYP1A2 Inhibitors
Topoisomerase II Inhibitors

Suppliers and Packaging for NDA: 019921

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OCUFLOX	ofloxacin	SOLUTION/DROPS;OPHTHALMIC	019921	NDA	Allergan, Inc.	11980-779	11980-779-05	1 BOTTLE, DROPPER in 1 CARTON (11980-779-05) / 5 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	0.3%
Approval Date:	Jul 30, 1993	TE:	AT	RLD:	Yes

Expired US Patents for NDA 019921

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Allergan	OCUFLOX	ofloxacin	SOLUTION/DROPS;OPHTHALMIC	019921-001	Jul 30, 1993	⤷ Sign Up	⤷ Sign Up
Allergan	OCUFLOX	ofloxacin	SOLUTION/DROPS;OPHTHALMIC	019921-001	Jul 30, 1993	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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