Details for New Drug Application (NDA): 022548

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NDA 022548 describes ZYMAXID, which is a drug marketed by Allergan and is included in one NDA. It is available from two suppliers. Additional details are available on the ZYMAXID profile page.

The generic ingredient in ZYMAXID is gatifloxacin. There are sixteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the gatifloxacin profile page.

Summary for 022548

Tradename:	ZYMAXID
Applicant:	Allergan
Ingredient:	gatifloxacin
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 022548

Suppliers and Packaging for NDA: 022548

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ZYMAXID	gatifloxacin	SOLUTION/DROPS;OPHTHALMIC	022548	NDA	Allergan, Inc.	0023-3615	0023-3615-01	1 BOTTLE, DROPPER in 1 CARTON (0023-3615-01) > 1 mL in 1 BOTTLE, DROPPER
ZYMAXID	gatifloxacin	SOLUTION/DROPS;OPHTHALMIC	022548	NDA	Allergan, Inc.	0023-3615	0023-3615-25	1 BOTTLE, DROPPER in 1 CARTON (0023-3615-25) > 2.5 mL in 1 BOTTLE, DROPPER

Paragraph IV (Patent) Challenges for 022548

Tradename	Dosage	Ingredient	NDA	Submissiondate
ZYMAXID	SOLUTION/DROPS;OPHTHALMIC	gatifloxacin	022548	2010-12-07

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	0.5%
Approval Date:	May 18, 2010	TE:	AT	RLD:	Yes

Expired US Patents for NDA 022548

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Allergan	ZYMAXID	gatifloxacin	SOLUTION/DROPS;OPHTHALMIC	022548-001	May 18, 2010	⤷ Sign up for a Free Trial	⤷ Sign up for a Free Trial
Allergan	ZYMAXID	gatifloxacin	SOLUTION/DROPS;OPHTHALMIC	022548-001	May 18, 2010	⤷ Sign up for a Free Trial	⤷ Sign up for a Free Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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