Fluvoxamine Maleate
FLUVOXAMINE extended-release capsules, for oral use Initial U.S. Approval: 2008
Approved
Approval ID
8bbd7e39-b9ab-4716-9522-aa8c4b92210e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 13, 2023
Manufacturers
FDA
Actavis Pharma, Inc.
DUNS: 119723554
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fluvoxamine Maleate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0228-2849
Application NumberANDA091482
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluvoxamine Maleate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 13, 2023
FDA Product Classification
INGREDIENTS (17)
AMMONIO METHACRYLATE COPOLYMER TYPE AInactive
Code: 8GQS4E66YY
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FLUVOXAMINE MALEATEActive
Quantity: 150 mg in 1 1
Code: 5LGN83G74V
Classification: ACTIB
AMMONIO METHACRYLATE COPOLYMER TYPE BInactive
Code: 161H3B14U2
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
Fluvoxamine Maleate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0228-2848
Application NumberANDA091482
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluvoxamine Maleate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 13, 2023
FDA Product Classification
INGREDIENTS (17)
FLUVOXAMINE MALEATEActive
Quantity: 100 mg in 1 1
Code: 5LGN83G74V
Classification: ACTIB
AMMONIO METHACRYLATE COPOLYMER TYPE AInactive
Code: 8GQS4E66YY
Classification: IACT
AMMONIO METHACRYLATE COPOLYMER TYPE BInactive
Code: 161H3B14U2
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT