"0378-0412-05" National Drug Code (NDC)

Fluvoxamine Maleate 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0412-05)
(Mylan Pharmaceuticals Inc.)

NDC Code0378-0412-05
Package Description500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0412-05)
Product NDC0378-0412
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameFluvoxamine Maleate
Non-Proprietary NameFluvoxamine Maleate
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20001220
Marketing Category NameANDA
Application NumberANDA075889
ManufacturerMylan Pharmaceuticals Inc.
Substance NameFLUVOXAMINE MALEATE
Strength50
Strength Unitmg/1
Pharmacy ClassesSerotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]

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