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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-408
Application NumberANDA076847
Product Classification
M
Marketing Category
C73584
G
Generic Name
SUMATRIPTAN SUCCINATE
Product Specifications
Route of AdministrationORAL
Effective DateOctober 11, 2012
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-950
Application NumberANDA076847
Product Classification
M
Marketing Category
C73584
G
Generic Name
SUMATRIPTAN SUCCINATE
Product Specifications
Route of AdministrationORAL
Effective DateOctober 11, 2012
FDA Product Classification
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