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FDA Product

Atorvastatin Calcium

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

Basic Information

Atorvastatin Calcium

43598-831

Regulatory Information

43598-831

ANDA214659

C73584

May 12, 2023

USA

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

HUMAN PRESCRIPTION DRUG LABEL

7

Company Information

802315887

Active Ingredients

CALCIUM CARBONATE

Code: H0G9379FGK

Class Code: IACT

Hydroxypropyl Cellulose, Unspecified

Code: 9XZ8H6N6OH

Class Code: IACT

magnesium stearate

Code: 70097M6I30

Class Code: IACT

Croscarmellose Sodium

Code: M28OL1HH48

Class Code: IACT

Microcrystalline Cellulose

Code: OP1R32D61U

Class Code: IACT

Hypromelloses

Code: 3NXW29V3WO

Class Code: IACT

lactose monohydrate

Code: EWQ57Q8I5X

Class Code: IACT

Polysorbate 80

Code: 6OZP39ZG8H

Class Code: IACT

Polyethylene Glycol, Unspecified

Code: 3WJQ0SDW1A

Class Code: IACT

titanium dioxide

Code: 15FIX9V2JP

Class Code: IACT

Talc

Code: 7SEV7J4R1U

Class Code: IACT

Atorvastatin Calcium Trihydrate

Quantity: 20 mg in 1 1

Code: 48A5M73Z4Q

Class Code: ACTIM

Active Moieties

atorvastatin

Code: A0JWA85V8F

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