SUMATRIPTAN SUCCINATE
Sumatriptan Succinate
Approved
Approval ID
77523882-3a1e-48ea-9bbb-9fffdd7aa415
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 11, 2012
Manufacturers
FDA
STAT Rx USA LLC
DUNS: 786036330
Products 2
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 Code16590-408
Application NumberANDA076847
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 11, 2012
Generic NameSUMATRIPTAN SUCCINATE
INGREDIENTS (10)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SUMATRIPTAN SUCCINATEActive
Quantity: 50 mg in 1 1
Code: J8BDZ68989
Classification: ACTIM
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
SUMATRIPTAN SUCCINATE
PRODUCT DETAILS
NDC Product Code16590-950
Application NumberANDA076847
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 11, 2012
Generic NameSUMATRIPTAN SUCCINATE
INGREDIENTS (10)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SUMATRIPTAN SUCCINATEActive
Quantity: 25 mg in 1 1
Code: J8BDZ68989
Classification: ACTIM
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT