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VIGAMOX

VIGAMOX® (moxifloxacin hydrochloride ophthalmic solution) 0.5% as base

Approved
Approval ID

68cca7e1-120c-4ac6-8851-15a17e11bd9f

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 13, 2011

Manufacturers
FDA

Rebel Distributors Corp

DUNS: 118802834

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

moxifloxacin hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code21695-968
Application NumberNDA021598
Product Classification
M
Marketing Category
C73594
G
Generic Name
moxifloxacin hydrochloride
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJune 14, 2011
FDA Product Classification

INGREDIENTS (6)

MOXIFLOXACIN HYDROCHLORIDEActive
Quantity: 5 mg in 1 mL
Code: C53598599T
Classification: ACTIM
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT

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VIGAMOX - FDA Drug Approval Details