FDA.reportPublic FDA data

Application 075889

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLUVOXAMINE MALEATEFLUVOXAMINE MALEATETABLET;ORAL25MGNoNo
002FLUVOXAMINE MALEATEFLUVOXAMINE MALEATETABLET;ORAL50MGNoNo
003FLUVOXAMINE MALEATEFLUVOXAMINE MALEATETABLET;ORAL100MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-0407Fluvoxamine Maleatefluvoxamine maleateMylan Pharmaceuticals Inc.ANDACurrent
0378-0407Fluvoxamine Maleatefluvoxamine maleateMylan Pharmaceuticals IncANDACurrent
0378-0412Fluvoxamine Maleatefluvoxamine maleateMylan Pharmaceuticals Inc.ANDACurrent
0378-0412Fluvoxamine Maleatefluvoxamine maleateMylan Pharmaceuticals IncANDACurrent
0378-0414Fluvoxamine Maleatefluvoxamine maleateMylan Pharmaceuticals Inc.ANDACurrent
0378-0414Fluvoxamine Maleatefluvoxamine maleateMylan Pharmaceuticals IncANDACurrent
51079-992Fluvoxamine Maleatefluvoxamine maleateMylan Institutional Inc.ANDACurrent
51079-992Fluvoxamine Maleatefluvoxamine maleateMylan Institutional Inc.ANDACurrent
51079-993Fluvoxamine Maleatefluvoxamine maleateMylan Institutional Inc.ANDACurrent
51079-993Fluvoxamine Maleatefluvoxamine maleateMylan Institutional Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
23781ORIG2007-05-09
31043ORIG2000-11-29