FDA.reportPublic FDA data

Application 075888

Type
ANDA
Sponsor
UPSHER SMITH LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLUVOXAMINE MALEATEFLUVOXAMINE MALEATETABLET;ORAL25MGNoNo
002FLUVOXAMINE MALEATEFLUVOXAMINE MALEATETABLET;ORAL50MGNoNo
003FLUVOXAMINE MALEATEFLUVOXAMINE MALEATETABLET;ORAL100MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0185-0017fluvoxamine maleatefluvoxamine maleateEon Labs, Inc.ANDACurrent
0185-0027fluvoxamine maleatefluvoxamine maleateEon Labs, Inc.ANDACurrent
0185-0157fluvoxamine maleatefluvoxamine maleateEon Labs, Inc.ANDACurrent
0832-1670Fluvoxamine maleateFluvoxamine maleateUpsher-Smith Laboratories, LLCANDACurrent
0832-1670Fluvoxamine maleateFluvoxamine maleateUpsher-Smith Laboratories, LLCANDACurrent
0832-1670Fluvoxamine maleateFluvoxamine maleateUpsher-Smith Laboratories, LLCANDACurrent
0832-1670Fluvoxamine maleateFluvoxamine maleateUpsher-Smith Laboratories, LLCANDACurrent
0832-1671Fluvoxamine maleateFluvoxamine maleateUpsher-Smith Laboratories, LLCANDACurrent
0832-1671Fluvoxamine maleateFluvoxamine maleateUpsher-Smith Laboratories, LLCANDACurrent
0832-1671Fluvoxamine maleateFluvoxamine maleateUpsher-Smith Laboratories, LLCANDACurrent
0832-1671Fluvoxamine maleateFluvoxamine maleateUpsher-Smith Laboratories, LLCANDACurrent
0832-1672Fluvoxamine maleateFluvoxamine maleateUpsher-Smith Laboratories, LLCANDACurrent
0832-1672Fluvoxamine maleateFluvoxamine maleateUpsher-Smith Laboratories, LLCANDACurrent
0832-1672Fluvoxamine maleateFluvoxamine maleateUpsher-Smith Laboratories, LLCANDACurrent
0832-1672Fluvoxamine maleateFluvoxamine maleateUpsher-Smith Laboratories, LLCANDACurrent
63629-4676fluvoxamine maleatefluvoxamine maleateBryant Ranch PrepackANDACurrent
70518-3153Fluvoxamine maleateFluvoxamine maleateREMEDYREPACK INC.ANDACurrent
70518-3153Fluvoxamine maleateFluvoxamine maleateREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44274ORIG2007-05-09
8819ORIG2000-11-29