FROVATRIPTAN
These highlights do not include all the information needed to use FROVATRIPTAN SUCCINATE TABLETS safely and effectively. See full prescribing information for FROVATRIPTAN SUCCINATE TABLETS.FROVATRIPTAN SUCCINATE tablets, for oral use Initial U.S. Approval: 2001
Approved
Approval ID
92c91060-c06e-4a8a-b586-a3fb25c33433
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 29, 2023
Manufacturers
FDA
Ingenus Pharmaceuticals, LLC
DUNS: 833250017
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 Code50742-299
Application NumberANDA213891
Product Classification
M
Marketing Category
C73584
G
Generic Name
frovatriptan succinate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 29, 2023
FDA Product Classification
INGREDIENTS (9)
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
FROVATRIPTAN SUCCINATEActive
Quantity: 2.5 mg in 1 1
Code: D28J6W18HY
Classification: ACTIM
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A CORNInactive
Code: AG9B65PV6B
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT