frovatriptan succinate
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
03a58215-dba7-4f63-8b98-d74d054a574a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 31, 2019
Manufacturers
FDA
Glenmark Pharmaceuticals Inc., USA
DUNS: 130597813
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 Code68462-694
Application NumberANDA204730
Product Classification
M
Marketing Category
C73584
G
Generic Name
frovatriptan succinate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 31, 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
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT