MedPath
FDA Product

Simvastatin

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

Basic Information

Simvastatin

43353-773

Regulatory Information

43353-773

ANDA078034

C73584

October 18, 2011

USA

Simvastatin TabletsTablet, Film CoatedRx Only.

HUMAN PRESCRIPTION DRUG LABEL

2

Company Information

128385585

Active Ingredients

FERRIC OXIDE RED

Code: 1K09F3G675

Class Code: IACT

ISOPROPYL ALCOHOL

Code: ND2M416302

Class Code: IACT

ASCORBIC ACID

Code: PQ6CK8PD0R

Class Code: IACT

HYPROMELLOSES

Code: 3NXW29V3WO

Class Code: IACT

BUTYLATED HYDROXYANISOLE

Code: REK4960K2U

Class Code: IACT

ANHYDROUS CITRIC ACID

Code: XF417D3PSL

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

POVIDONE

Code: FZ989GH94E

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

TRIETHYL CITRATE

Code: 8Z96QXD6UM

Class Code: IACT

SIMVASTATIN

Quantity: 20 mg in 1 1

Code: AGG2FN16EV

Class Code: ACTIB

Active Moieties

SIMVASTATIN

Code: AGG2FN16EV

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