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FDA Approval

MOXIFLOXACIN

CompanyDirect Rx (DUNS: 079254320)

Effective Date

March 8, 2022

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Moxifloxacin(5 mg in 1 mL)

Registrants (1)

DUNS Number

079254320

Manufacturing Establishments (1)

Labeler

Direct Rx

Registrant

Direct Rx

DUNS Number

079254320

Products (1)

MOXIFLOXACIN

NDC Product Code

72189-334

Application Number

ANDA202916

Marketing Category

ANDA (C73584)

Route of Administration

OPHTHALMIC

Effective Date

March 8, 2022

Ingredients

BORIC ACIDInactive

Code: R57ZHV85D4Class: IACT

MoxifloxacinActive

Code: C53598599TClass: ACTIMQuantity: 5 mg in 1 mL

WATERInactive

Code: 059QF0KO0RClass: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACT

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

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