MedPath
FDA Product

simvastatin

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

Basic Information

simvastatin

68788-9747

Regulatory Information

68788-9747

ANDA078155

C73584

September 22, 2023

USA

These highlights do not include all the information needed to use SIMVASTATIN TABLETS safely and effectively. See full prescribing information for SIMVASTATIN TABLETS. SIMVASTATIN tablets, for oral use Initial U.S. Approval:1991

HUMAN PRESCRIPTION DRUG LABEL

12

Company Information

791119022

Active Ingredients

HYDROXYPROPYL CELLULOSE (1600000 WAMW)

Code: RFW2ET671P

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

HYPROMELLOSE 2910 (5 MPA.S)

Code: R75537T0T4

Class Code: IACT

FERRIC OXIDE RED

Code: 1K09F3G675

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

BUTYLATED HYDROXYANISOLE

Code: REK4960K2U

Class Code: IACT

CITRIC ACID MONOHYDRATE

Code: 2968PHW8QP

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

ASCORBIC ACID

Code: PQ6CK8PD0R

Class Code: IACT

TRIETHYL CITRATE

Code: 8Z96QXD6UM

Class Code: IACT

SIMVASTATIN

Quantity: 10 mg in 1 1

Code: AGG2FN16EV

Class Code: ACTIB

Active Moieties

SIMVASTATIN

Code: AGG2FN16EV

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