MedPath
FDA Product

Levofloxacin

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

Basic Information

Levofloxacin

71205-002

Regulatory Information

71205-002

ANDA202801

C73584

May 1, 2022

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 Tablet, Film Coated for Oral useInitial U.S. Approval: 1996

HUMAN PRESCRIPTION DRUG LABEL

6

Company Information

Proficient Rx LP

079196022

Active Ingredients

LEVOFLOXACIN

Quantity: 500 mg in 1 1

Code: 6GNT3Y5LMF

Class Code: ACTIM

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

HYPROMELLOSE, UNSPECIFIED

Code: 3NXW29V3WO

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

POLYETHYLENE GLYCOL, UNSPECIFIED

Code: 3WJQ0SDW1A

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

POLYSORBATE 80

Code: 6OZP39ZG8H

Class Code: IACT

FERRIC OXIDE RED

Code: 1K09F3G675

Class Code: IACT

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

POVIDONE, UNSPECIFIED

Code: FZ989GH94E

Class Code: IACT

Active Moieties

LEVOFLOXACIN ANHYDROUS

Code: RIX4E89Y14

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