Sumatriptan Succinate
Sumatriptan succinate
Approved
Approval ID
2e5048c1-735f-434d-ae4c-5e822a95a2c4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 29, 2011
Manufacturers
FDA
H.J. Harkins Company, Inc.
DUNS: 147681894
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52959-510
Application NumberANDA076847
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sumatriptan Succinate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 29, 2011
FDA Product Classification
INGREDIENTS (10)
triacetinInactive
Code: XHX3C3X673
Classification: IACT
sumatriptan succinateActive
Quantity: 100 mg in 1 1
Code: J8BDZ68989
Classification: ACTIM
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
mannitolInactive
Code: 3OWL53L36A
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT