Simvastatin
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
Approved
Approval ID
a753846e-4cd5-4ddc-a4f2-c45da571c883
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 23, 2021
Manufacturers
FDA
Aphena Pharma Solutions - Tennessee, LLC
DUNS: 128385585
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Simvastatin
PRODUCT DETAILS
NDC Product Code71610-622
Application NumberANDA078034
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 23, 2021
Generic NameSimvastatin
INGREDIENTS (17)
ASCORBIC ACIDInactive
Code: PQ6CK8PD0R
Classification: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
SIMVASTATINActive
Quantity: 20 mg in 1 1
Code: AGG2FN16EV
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
AlcoholInactive
Code: 3K9958V90M
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
Starch, Pregelatinized CornInactive
Code: O8232NY3SJ
Classification: IACT
PovidoneInactive
Code: FZ989GH94E
Classification: IACT
Simvastatin
PRODUCT DETAILS
NDC Product Code71610-623
Application NumberANDA078034
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 23, 2021
Generic NameSimvastatin
INGREDIENTS (17)
SIMVASTATINActive
Quantity: 40 mg in 1 1
Code: AGG2FN16EV
Classification: ACTIB
ASCORBIC ACIDInactive
Code: PQ6CK8PD0R
Classification: IACT
Anhydrous Citric AcidInactive
Code: XF417D3PSL
Classification: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
AlcoholInactive
Code: 3K9958V90M
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
PovidoneInactive
Code: FZ989GH94E
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Starch, Pregelatinized CornInactive
Code: O8232NY3SJ
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT