FDA.reportPublic FDA data

Application 075797

Type
ANDA
Sponsor
MAYNE PHARMA

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0179-0224Tamoxifen CitrateTamoxifen CitrateKAISER FOUNDATION HOSPITALSANDACurrent
51407-439Tamoxifen CitrateTamoxifen CitrateGolden State Medical Supply, Inc.ANDACurrent
51407-439Tamoxifen CitrateTamoxifen CitrateGolden State Medical Supply, Inc.ANDACurrent
51407-439Tamoxifen CitrateTamoxifen CitrateGolden State Medical Supply, Inc.ANDACurrent
51407-440Tamoxifen CitrateTamoxifen CitrateGolden State Medical Supply, Inc.ANDACurrent
51407-440Tamoxifen CitrateTamoxifen CitrateGolden State Medical Supply, Inc.ANDACurrent
51407-440Tamoxifen CitrateTamoxifen CitrateGolden State Medical Supply, Inc.ANDACurrent
51862-446Tamoxifen CitrateTamoxifen CitrateMayne Pharma Inc.ANDACurrent
51862-446Tamoxifen CitrateTamoxifen CitrateMayne Pharma Inc.ANDACurrent
51862-446Tamoxifen CitrateTamoxifen CitrateMayne Pharma Inc.ANDACurrent
51862-446Tamoxifen CitrateTamoxifen CitrateMayne Pharma Inc.ANDACurrent
51862-446Tamoxifen CitrateTamoxifen CitrateMayne Pharma Inc.ANDACurrent
51862-447Tamoxifen CitrateTamoxifen CitrateMayne Pharma Inc.ANDACurrent
51862-447Tamoxifen CitrateTamoxifen CitrateMayne Pharma Inc.ANDACurrent
51862-447Tamoxifen CitrateTamoxifen CitrateMayne Pharma Inc.ANDACurrent
51862-447Tamoxifen CitrateTamoxifen CitrateMayne Pharma Inc.ANDACurrent
51862-642Tamoxifen CitrateTamoxifen CitrateMayne Pharma Inc.ANDACurrent
51862-642Tamoxifen CitrateTamoxifen CitrateMayne Pharma Inc.ANDACurrent
51862-643Tamoxifen CitrateTamoxifen CitrateMayne Pharma Inc.ANDACurrent
51862-643Tamoxifen CitrateTamoxifen CitrateMayne Pharma Inc.ANDACurrent
60429-909Tamoxifen CitrateTamoxifen CitrateGolden State Medical Supply, Inc.ANDACurrent
60429-909Tamoxifen CitrateTamoxifen CitrateGolden State Medical Supply, Inc.ANDACurrent
60429-909Tamoxifen CitrateTamoxifen CitrateGolden State Medical Supply, Inc.ANDACurrent
60429-909Tamoxifen CitrateTamoxifen CitrateGolden State Medical Supply, Inc.ANDACurrent
60429-909Tamoxifen CitrateTamoxifen CitrateGolden State Medical Supply, Inc.ANDACurrent
60429-910Tamoxifen CitrateTamoxifen CitrateGolden State Medical Supply, Inc.ANDACurrent
60429-910Tamoxifen CitrateTamoxifen CitrateGolden State Medical Supply, Inc.ANDACurrent
60429-910Tamoxifen CitrateTamoxifen CitrateGolden State Medical Supply, Inc.ANDACurrent
60429-910Tamoxifen CitrateTamoxifen CitrateGolden State Medical Supply, Inc.ANDACurrent
60429-910Tamoxifen CitrateTamoxifen CitrateGolden State Medical Supply, Inc.ANDACurrent
63739-143Tamoxifen CitrateTamoxifen CitrateMcKesson Corporation dba SKY PackagingANDACurrent
63739-143Tamoxifen CitrateTamoxifen CitrateMcKesson Corporation dba SKY PackagingANDACurrent
63739-143Tamoxifen CitrateTamoxifen CitrateMcKesson Corporation dba SKY PackagingANDACurrent
63739-269Tamoxifen CitrateTamoxifen CitrateMcKesson Corporation dba SKY PackagingANDACurrent
63739-269Tamoxifen CitrateTamoxifen CitrateMcKesson Corporation dba SKY PackagingANDACurrent
63739-269Tamoxifen CitrateTamoxifen CitrateMcKesson Corporation dba SKY PackagingANDACurrent
63739-269Tamoxifen CitrateTamoxifen CitrateMcKesson Corporation dba SKY PackagingANDACurrent
65084-269Tamoxifen CitrateTamoxifen CitrateMcKesson Corporation dba RX PakANDACurrent
71335-0237Tamoxifen CitrateTamoxifen CitrateBryant Ranch PrepackANDACurrent
71335-0237Tamoxifen CitrateTamoxifen CitrateBryant Ranch PrepackANDACurrent
71335-0237Tamoxifen CitrateTamoxifen CitrateBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8794ORIG2004-06-18