IMITREX
SUMATRIPTAN
Approved
Approval ID
34b663e0-e40c-366f-e054-00144ff8d46c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 7, 2016
Manufacturers
FDA
DIRECT RX
DUNS: 079254320
Products 1
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 Code61919-408
Application NumberANDA078327
Product Classification
M
Marketing Category
C73584
G
Generic Name
SUMATRIPTAN
Product Specifications
Route of AdministrationORAL
Effective DateJune 7, 2016
FDA Product Classification
INGREDIENTS (7)
SUMATRIPTAN SUCCINATEActive
Quantity: 50 mg in 1 1
Code: J8BDZ68989
Classification: ACTIM
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: L11K75P92J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT