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 useInitial U.S. Approval: 2001
Approved
Approval ID
94b996dc-ddc4-41ce-9a9f-3d91cb187473
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 30, 2019
Manufacturers
FDA
Amneal Pharmaceuticals NY LLC
DUNS: 123797875
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 Code69238-1539
Application NumberANDA211292
Product Classification
M
Marketing Category
C73584
G
Generic Name
Frovatriptan succinate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 30, 2019
FDA Product Classification
INGREDIENTS (11)
FROVATRIPTAN SUCCINATEActive
Quantity: 2.5 mg in 1 1
Code: D28J6W18HY
Classification: ACTIM
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT