IMITREX
IMITREX (sumatriptan succinate)Tablets
Approved
Approval ID
a169b0c0-600f-4072-8ab7-fafc386eab80
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 28, 2010
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
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 Code21695-154
Application NumberNDA020132
Product Classification
M
Marketing Category
C73594
G
Generic Name
sumatriptan succinate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 23, 2008
FDA Product Classification
INGREDIENTS (6)
SUMATRIPTAN SUCCINATEActive
Quantity: 50 mg in 1 1
Code: J8BDZ68989
Classification: ACTIB
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT