MedPath
FDA Product

Levofloxacin

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

Basic Information

Levofloxacin

0781-5792

Regulatory Information

0781-5792

ANDA077438

C73584

August 19, 2019

USA

These highlights do not include all the information needed to use LEVOFLOXACIN TABLETS safely and effectively. See full prescribing information for LEVOFLOXACIN TABLETS. LEVOFLOXACIN tablets, for oral useInitial U.S. Approval: 1996

HUMAN PRESCRIPTION DRUG LABEL

18

Company Information

Sandoz Inc

005387188

Active Ingredients

LEVOFLOXACIN

Quantity: 750 mg in 1 1

Code: 6GNT3Y5LMF

Class Code: ACTIM

Inactive Ingredients

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

GLYCERYL DIBEHENATE

Code: R8WTH25YS2

Class Code: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIED

Code: 9XZ8H6N6OH

Class Code: IACT

HYPROMELLOSE 2910 (15 MPA.S)

Code: 36SFW2JZ0W

Class Code: IACT

POLYETHYLENE GLYCOL 400

Code: B697894SGQ

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

POVIDONE K30

Code: U725QWY32X

Class Code: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATO

Code: 5856J3G2A2

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

Active Moieties

LEVOFLOXACIN ANHYDROUS

Code: RIX4E89Y14

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