FDA Product

ofloxacin

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

ofloxacin

FDA Product Code

70756-607

Regulatory Information

NDC Product Code

70756-607

Application Number

ANDA215886

Marketing Category

C73584

Effective Date

August 31, 2023

Territorial Authority

USA

FDA Title

Ofloxacin Ophthalmic Solution USP, 0.3% sterile

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

9

Company Information

ManufacturerLifestar Pharma LLC

DUNS Number

080268943

Active Ingredients

BENZALKONIUM CHLORIDE

Code: F5UM2KM3W7

Class Code: IACT

Quantity: 3 mg in 1 mL

Code: A4P49JAZ9H

Class Code: ACTIB

HYDROCHLORIC ACID

Code: QTT17582CB

Class Code: IACT

SODIUM CHLORIDE

Code: 451W47IQ8X

Class Code: IACT

SODIUM HYDROXIDE

Code: 55X04QC32I

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

Active Moieties

OFLOXACIN

Code: A4P49JAZ9H

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