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Last Updated: June 3, 2020

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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:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.5%
Approval Date:May 18, 2010TE:ATRLD:Yes

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