FDA.reportPublic FDA data

Application 074732

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TAMOXIFEN CITRATETAMOXIFEN CITRATETABLET;ORALEQ 20MG BASENoNo
002TAMOXIFEN CITRATETAMOXIFEN CITRATETABLET;ORALEQ 10MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-0144Tamoxifen CitrateTamoxifen CitrateMylan Pharmaceuticals Inc.ANDACurrent
0378-0144Tamoxifen CitrateTamoxifen CitrateMylan Pharmaceuticals Inc.ANDACurrent
0378-0144Tamoxifen CitrateTamoxifen CitrateMylan Pharmaceuticals Inc.ANDACurrent
0378-0274Tamoxifen CitrateTamoxifen CitrateMylan Pharmaceuticals Inc.ANDACurrent
0378-0274Tamoxifen CitrateTamoxifen CitrateMylan Pharmaceuticals Inc.ANDACurrent
0378-0274Tamoxifen CitrateTamoxifen CitrateMylan Pharmaceuticals Inc.ANDACurrent
70518-2721Tamoxifen CitrateTamoxifen CitrateREMEDYREPACK INC.ANDACurrent
70518-2721Tamoxifen CitrateTamoxifen CitrateREMEDYREPACK INC.ANDACurrent
70518-2721Tamoxifen CitrateTamoxifen CitrateREMEDYREPACK INC.ANDACurrent
71335-0893Tamoxifen CitrateTamoxifen CitrateBryant Ranch PrepackANDACurrent
71335-0893Tamoxifen CitrateTamoxifen CitrateBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8438ORIG2004-06-18