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FDA Product

LEVOFLOXACIN

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

Basic Information

LEVOFLOXACIN

61919-426

Regulatory Information

61919-426

ANDA202801

C73584

August 7, 2023

USA

LEVOFLOXACIN

HUMAN PRESCRIPTION DRUG LABEL

7

Company Information

DIRECT RX

079254320

Active Ingredients

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

POLYSORBATE 80

Code: 6OZP39ZG8H

Class Code: IACT

POLYETHYLENE GLYCOL, UNSPECIFIED

Code: 3WJQ0SDW1A

Class Code: IACT

POVIDONE

Code: FZ989GH94E

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

FERRIC OXIDE RED

Code: 1K09F3G675

Class Code: IACT

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

LEVOFLOXACIN

Quantity: 500 mg in 1 1

Code: 6GNT3Y5LMF

Class Code: ACTIM

HYPROMELLOSES

Code: 3NXW29V3WO

Class Code: IACT

Active Moieties

LEVOFLOXACIN ANHYDROUS

Code: RIX4E89Y14

CROSCARMELLOSE

Code: 029TFK992N

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