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FDA Product

ATORVASTATIN CALCIUM

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

Basic Information

ATORVASTATIN CALCIUM

0615-8008

Regulatory Information

0615-8008

ANDA090548

C73584

October 24, 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

32

Company Information

NCS HealthCare of KY, LLC dba Vangard Labs

050052943

Active Ingredients

CALCIUM ACETATE

Code: Y882YXF34X

Class Code: IACT

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

SODIUM CARBONATE

Code: 45P3261C7T

Class Code: IACT

Cellulose, Microcrystalline

Code: OP1R32D61U

Class Code: IACT

POLYETHYLENE GLYCOL 8000

Code: Q662QK8M3B

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

HYPROMELLOSE, UNSPECIFIED

Code: 3NXW29V3WO

Class Code: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)

Code: RFW2ET671P

Class Code: IACT

ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE

Quantity: 40 mg in 1 1

Code: YRZ789OWMI

Class Code: ACTIM

Active Moieties

ATORVASTATIN

Code: A0JWA85V8F

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