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
080000063
Active Ingredients
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