Sumavel DosePro
These highlights do not include all the information needed to use Sumavel DosePro safely and effectively. See full prescribing information for Sumavel DosePro. Sumavel DosePro (sumatriptan injection), for subcutaneous use Initial U.S. Approval: 1992
Approved
Approval ID
6a4c0c2f-497d-4c5c-84c4-9ab42780cbde
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 7, 2014
Manufacturers
FDA
Zogenix, Inc.
DUNS: 867785441
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
sumatriptan
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43376-104
Application NumberNDA022239
Product Classification
M
Marketing Category
C73594
G
Generic Name
sumatriptan
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateFebruary 11, 2014
FDA Product Classification
INGREDIENTS (3)
SUMATRIPTAN SUCCINATEActive
Quantity: 4 mg in 0.5 mL
Code: J8BDZ68989
Classification: ACTIM
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
sumatriptan
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43376-106
Application NumberNDA022239
Product Classification
M
Marketing Category
C73594
G
Generic Name
sumatriptan
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateFebruary 11, 2014
FDA Product Classification
INGREDIENTS (3)
SUMATRIPTAN SUCCINATEActive
Quantity: 6 mg in 0.5 mL
Code: J8BDZ68989
Classification: ACTIM
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT