Basic Information
SIMVASTATIN
60760-580
Regulatory Information
60760-580
ANDA078103
C73584
April 14, 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
1
Company Information
063050751
Active Ingredients
ASCORBIC ACID
Code: PQ6CK8PD0R
Class Code: IACT
BUTYLATED HYDROXYANISOLE
Code: REK4960K2U
Class Code: IACT
CELLULOSE, MICROCRYSTALLINE
Code: OP1R32D61U
Class Code: IACT
CITRIC ACID MONOHYDRATE
Code: 2968PHW8QP
Class Code: IACT
FERROSOFERRIC OXIDE
Code: XM0M87F357
Class Code: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
Code: RFW2ET671P
Class Code: IACT
LACTOSE MONOHYDRATE
Code: EWQ57Q8I5X
Class Code: IACT
STARCH, CORN
Code: O8232NY3SJ
Class Code: IACT
HYPROMELLOSES
Code: 3NXW29V3WO
Class Code: IACT
TALC
Code: 7SEV7J4R1U
Class Code: IACT
TITANIUM DIOXIDE
Code: 15FIX9V2JP
Class Code: IACT
MAGNESIUM STEARATE
Code: 70097M6I30
Class Code: IACT
Active Moieties
SIMVASTATIN
Code: AGG2FN16EV