Moxifloxacin Hydrochloride Monohydrate

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DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INTRAVENOUS - 400MG/250ML (1.6MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION/DROPS;OPHTHALMIC - EQ 0.5% BASE

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GLOBAL SALES INFORMATION

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PATENTS & EXCLUSIVITIES

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ANALYTICAL

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USFDA APPLICATION NUMBER - 21598 / DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 0.5% BASE

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MOXIFLOXACIN HYDROCHLORIDE(UNII: C53598599T) (MOXIFLOXACIN - UNII:U188XYD42P)	MOXIFLOXACIN	5mg in 1

Inactive Ingredients

Ingredient Name	A-S Medication Solutions	Alcon Laboratories, Inc.	Direct Rx	Lake Erie Medical DBA Quality Care Products LLC	Lupin Pharmaceuticals, Inc.	Preferred Pharmaceuticals Inc.	REMEDYREPACK INC.
BORIC ACID(R57ZHV85D4)
HYDROCHLORIC ACID(QTT17582CB)
SODIUM CHLORIDE(451W47IQ8X)
SODIUM HYDROXIDE(55X04QC32I)
WATER(059QF0KO0R)

Drug Product Composition: Moxifloxacin Hydrochloride Monohydrate