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FDA Approval

Moxifloxacin

CompanyAkorn (DUNS: 117696770)

Effective Date

November 30, 2021

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Moxifloxacin(5 mg in 1 mL)

Registrants (1)

Akorn Operating Company LLC

DUNS Number

117693100

Manufacturing Establishments (1)

Labeler

Akorn

Registrant

Akorn Operating Company LLC

DUNS Number

117696840

Products (1)

Moxifloxacin

NDC Product Code

17478-519

Application Number

ANDA202916

Marketing Category

ANDA (C73584)

Route of Administration

OPHTHALMIC

Effective Date

July 6, 2017

Ingredients

MoxifloxacinActive

Code: C53598599TClass: ACTIMQuantity: 5 mg in 1 mL

Sodium ChlorideInactive

Code: 451W47IQ8XClass: IACT

Boric AcidInactive

Code: R57ZHV85D4Class: IACT

WaterInactive

Code: 059QF0KO0RClass: IACT

Hydrochloric AcidInactive

Code: QTT17582CBClass: IACT

Sodium HydroxideInactive

Code: 55X04QC32IClass: IACT

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