sumatriptan succinate
These highlights do not include all the information needed to use SUMATRIPTAN SUCCINATE TABLETS safely and effectively. See full prescribing information for SUMATRIPTAN SUCCINATE TABLETS . SUMATRIPTAN SUCCINATE tablets, for oral use Initial U.S. Approval: 1992
Approved
Approval ID
f56c3681-bb45-429d-a266-90cd4cfbcec9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 15, 2021
Manufacturers
FDA
Quality Care Products, LLC
DUNS: 831276758
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
sumatriptan succinate
PRODUCT DETAILS
NDC Product Code55700-846
Application NumberANDA078295
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMarch 5, 2020
Generic Namesumatriptan succinate
INGREDIENTS (12)
D&C RED NO. 27Inactive
Code: 2LRS185U6K
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SUMATRIPTAN SUCCINATEActive
Quantity: 100 mg in 1 1
Code: J8BDZ68989
Classification: ACTIM
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: L11K75P92J
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT