FROVA
Approved
Approval ID
c0703630-9ce8-4259-841e-71fd2019fa66
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 27, 2018
Manufacturers
FDA
Endo Pharmaceuticals, Inc.
DUNS: 178074951
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
frovatriptan succinate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63481-025
Application NumberNDA021006
Product Classification
M
Marketing Category
C73594
G
Generic Name
frovatriptan succinate
Product Specifications
Route of AdministrationORAL
Effective DateAugust 27, 2018
FDA Product Classification
INGREDIENTS (10)
FROVATRIPTAN SUCCINATEActive
Quantity: 2.5 mg in 1 1
Code: D28J6W18HY
Classification: ACTIM
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
POLYETHYLENE GLYCOL 3000Inactive
Code: SA1B764746
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT