Fluvoxamine Maleate
These highlights do not include all the information needed to use FLUVOXAMINE MALEATE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for FLUVOXAMINE MALEATE EXTENDED-RELEASE CAPSULES.FLUVOXAMINE MALEATE extended-release capsules, for oral administrationInitial U.S. Approval: 2008
Approved
Approval ID
d492230c-f56a-4759-ba86-7090b9f44063
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 12, 2023
Manufacturers
FDA
Par Pharmaceutical, Inc.
DUNS: 092733690
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 Code10370-176
Application NumberANDA091476
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluvoxamine Maleate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 12, 2023
FDA Product Classification
INGREDIENTS (15)
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
FLUVOXAMINE MALEATEActive
Quantity: 150 mg in 1 1
Code: 5LGN83G74V
Classification: ACTIB
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
HYDROXYPROPYL CELLULOSE (70000 WAMW)Inactive
Code: 66O7AQV0RT
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
Fluvoxamine Maleate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code10370-175
Application NumberANDA091476
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluvoxamine Maleate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 12, 2023
FDA Product Classification
INGREDIENTS (18)
FLUVOXAMINE MALEATEActive
Quantity: 100 mg in 1 1
Code: 5LGN83G74V
Classification: ACTIB
GELATINInactive
Code: 2G86QN327L
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
HYDROXYPROPYL CELLULOSE (70000 WAMW)Inactive
Code: 66O7AQV0RT
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT