Sumatriptan
These highlights do not include all the information needed to use SUMATRIPTAN INJECTION safely and effectively. See full prescribing information for SUMATRIPTAN INJECTION. SUMATRIPTAN injection, for subcutaneous use Initial U.S. Approval: 1992
Approved
Approval ID
53c62307-bd19-4418-b1b0-c0274b5595df
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 22, 2021
Manufacturers
FDA
Somerset Therapeutics, LLC
DUNS: 079947873
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Sumatriptan
PRODUCT DETAILS
NDC Product Code70069-804
Application NumberANDA213998
Marketing CategoryC73584
Route of AdministrationSUBCUTANEOUS
Effective DateJuly 30, 2021
Generic NameSumatriptan
INGREDIENTS (3)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 3.5 mg in 0.5 mL
Code: 451W47IQ8X
Classification: IACT
SUMATRIPTAN SUCCINATEActive
Quantity: 6 mg in 0.5 mL
Code: J8BDZ68989
Classification: ACTIM