Sumatriptan Succinate
SUMATRIPTAN SUCCINATE TABLETS022202230224Rx only
Approved
Approval ID
2fbc01fb-b787-4ff1-bb9f-280dfe975531
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 22, 2010
Manufacturers
FDA
MedVantx, Inc.
DUNS: 806427725
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 Code66116-413
Application NumberANDA076840
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sumatriptan Succinate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 3, 2009
FDA Product Classification
INGREDIENTS (9)
SUMATRIPTAN SUCCINATEActive
Quantity: 50 mg in 1 1
Code: J8BDZ68989
Classification: ACTIM
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT