MedPath
FDA Product

Simvastatin

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

Basic Information

Simvastatin

70377-001

Regulatory Information

70377-001

ANDA078034

C73584

October 13, 2021

USA

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

HUMAN PRESCRIPTION DRUG LABEL

9

Company Information

Biocon Pharma Inc,

080000063

Active Ingredients

SIMVASTATIN

Quantity: 5 mg in 1 1

Code: AGG2FN16EV

Class Code: ACTIB

ASCORBIC ACID

Code: PQ6CK8PD0R

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

Starch, Pregelatinized Corn

Code: O8232NY3SJ

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

Silicon Dioxide

Code: ETJ7Z6XBU4

Class Code: IACT

ALCOHOL

Code: 3K9958V90M

Class Code: IACT

HYPROMELLOSE, UNSPECIFIED

Code: 3NXW29V3WO

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

POVIDONE, UNSPECIFIED

Code: FZ989GH94E

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

Povidone

Code: FZ989GH94E

Class Code: IACT

TRIETHYL CITRATE

Code: 8Z96QXD6UM

Class Code: IACT

BUTYLATED HYDROXYANISOLE

Code: REK4960K2U

Class Code: IACT

ANHYDROUS CITRIC ACID

Code: XF417D3PSL

Class Code: IACT

HYPROMELLOSES

Code: 3NXW29V3WO

Class Code: IACT

Active Moieties

SIMVASTATIN

Code: AGG2FN16EV

© Copyright 2025. All Rights Reserved by MedPath