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FDA Approval

Fluvoxamine Maleate

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company

Par Pharmaceutical, Inc.

DUNS: 092733690

Effective Date

October 12, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Fluvoxamine(150 mg in 1 1)

Products2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Fluvoxamine Maleate

Product Details

NDC Product Code

10370-176

Application Number

ANDA091476

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

October 12, 2023

Ingredients

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

FluvoxamineActive

Code: 5LGN83G74VClass: ACTIBQuantity: 150 mg in 1 1

ISOPROPYL ALCOHOLInactive

Code: ND2M416302Class: IACT

ETHYLCELLULOSESInactive

Code: 7Z8S9VYZ4BClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

HYDROXYPROPYL CELLULOSE (70000 WAMW)Inactive

Code: 66O7AQV0RTClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

POVIDONEInactive

Code: FZ989GH94EClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

D&C RED NO. 28Inactive

Code: 767IP0Y5NHClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UMClass: IACT

Fluvoxamine Maleate

Product Details

NDC Product Code

10370-175

Application Number

ANDA091476

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

October 12, 2023

Ingredients

FluvoxamineActive

Code: 5LGN83G74VClass: ACTIBQuantity: 100 mg in 1 1

GELATINInactive

Code: 2G86QN327LClass: IACT

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

ETHYLCELLULOSESInactive

Code: 7Z8S9VYZ4BClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

HYDROXYPROPYL CELLULOSE (70000 WAMW)Inactive

Code: 66O7AQV0RTClass: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302Class: IACT

POVIDONEInactive

Code: FZ989GH94EClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UMClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

D&C RED NO. 28Inactive

Code: 767IP0Y5NHClass: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQKClass: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

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