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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
Actavis Pharma, Inc.
DUNS: 119723554
Effective Date
October 13, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
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
0228-2849
Application Number
ANDA091482
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
October 13, 2023
AMMONIO METHACRYLATE COPOLYMER TYPE AInactive
Code: 8GQS4E66YYClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
Code: 5LGN83G74VClass: ACTIBQuantity: 150 mg in 1 1
AMMONIO METHACRYLATE COPOLYMER TYPE BInactive
Code: 161H3B14U2Class: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UMClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4TClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT

Fluvoxamine Maleate

Product Details

NDC Product Code
0228-2848
Application Number
ANDA091482
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
October 13, 2023
Code: 5LGN83G74VClass: ACTIBQuantity: 100 mg in 1 1
AMMONIO METHACRYLATE COPOLYMER TYPE AInactive
Code: 8GQS4E66YYClass: IACT
AMMONIO METHACRYLATE COPOLYMER TYPE BInactive
Code: 161H3B14U2Class: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UMClass: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4TClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
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