IMITREX
IMITREX (sumatriptan succinate)InjectionFor Subcutaneous Use Only.
Approved
Approval ID
413cb899-509f-40cb-b898-c44af9611ce7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 12, 2011
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-3180
Application NumberNDA020080
Product Classification
M
Marketing Category
C73594
G
Generic Name
sumatriptan succinate
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateDecember 12, 2011
FDA Product Classification
INGREDIENTS (3)
SUMATRIPTAN SUCCINATEActive
Quantity: 6 mg in 0.5 mL
Code: J8BDZ68989
Classification: ACTIM
SODIUM CHLORIDEInactive
Quantity: 3.5 mg in 0.5 mL
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT