Tamoxifen Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Mylan Pharmaceuticals Inc. (2013-04-09)
Oldest Current Product
1994-04-26
License(s)
ANDA
RxNORM
ORAL TABLET\TAMOXIFEN
FDAOB
ORAL\TABLET\TAMOXIFEN CITRATE
SPL Active
ORAL\TABLET, FILM COATED\TAMOXIFEN CITRATE
ORAL\TABLET\TAMOXIFEN CITRATE
SPL Moiety
ORAL\TABLET, FILM COATED\TAMOXIFEN
ORAL\TABLET\TAMOXIFEN

product(s) by strength(s)

tamoxifen 10 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000930784ANDATeva Pharmaceuticals Usa Inc2003-02-20TAMOXIFEN CITRATEORALTABLET, FILM COATEDANDA075797407a372d-4448-4d53-afd4-eb0e74bbc336
2003780144ANDAMylan Pharmaceuticals Inc.2003-02-20TAMOXIFEN CITRATEORALTABLETANDA0747327ee3d3d2-85d1-4018-8e70-5ed8a64ae1f0
3005912472ANDAWatson Laboratories, Inc.2011-08-15TAMOXIFEN CITRATEORALTABLETANDA0709299b8a4211-120f-4981-ad69-928accb97637

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1001791952ANDAKaiser Foundations Hospitals2008-03-24TAMOXIFEN CITRATEORALTABLET, FILM COATED000930784ANDA07579761c988cc-a5bf-4cd2-81fd-4442a940622f
2548683004ANDAPhysicians Total Care, Inc.1994-04-26TAMOXIFEN CITRATEORALTABLET, FILM COATED000930784ANDA07579786dcde0e-347c-49e1-8b38-ad106a25c9af
3637390269ANDAMckesson Packaging Services A Business Unit Of Mckesson Corporation2007-09-14TAMOXIFEN CITRATEORALTABLET000930784ANDA075797151ce76c-2d44-4c82-850d-ab213bea4d6b
4680840924ANDAAmerican Health Packaging2015-03-31TAMOXIFEN CITRATEORALTABLET005912472ANDA070929f5ffe9dd-f76d-4aab-9473-81e33b26710b

tamoxifen 20 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000930782ANDATeva Pharmaceuticals Usa Inc2003-02-21TAMOXIFEN CITRATEORALTABLET, FILM COATEDANDA074858407a372d-4448-4d53-afd4-eb0e74bbc336
2003780274ANDAMylan Pharmaceuticals Inc.2003-02-20TAMOXIFEN CITRATEORALTABLETANDA0747327ee3d3d2-85d1-4018-8e70-5ed8a64ae1f0
3005912473ANDAWatson Laboratories, Inc.2011-08-15TAMOXIFEN CITRATEORALTABLETANDA0709299b8a4211-120f-4981-ad69-928accb97637

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548684287ANDAPhysicians Total Care, Inc.2005-01-17TAMOXIFEN CITRATEORALTABLET, FILM COATED000930782ANDA07485886dcde0e-347c-49e1-8b38-ad106a25c9af
2636294413ANDABryant Ranch Prepack2011-03-07TAMOXIFEN CITRATEORALTABLET005912233ANDA0709292720c127-ec86-42ea-97e7-88dd6a195cdb
3680840935ANDAAmerican Health Packaging2015-03-31TAMOXIFEN CITRATEORALTABLET005912473ANDA070929f5ffe9dd-f76d-4aab-9473-81e33b26710b

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA070929TAMOXIFEN CITRATEACTAVIS LABORATORIES FL INC2003-02-20ANDA070929_001, ANDA070929_002
2ANDA074504TAMOXIFEN CITRATETrueTEVA PHARMACEUTICALS USA INC2003-04-28ANDA074504_001, ANDA074504_002
3ANDA074539TAMOXIFEN CITRATETruePHARMACHEMIE BV2003-03-31ANDA074539_001
4ANDA074732TAMOXIFEN CITRATEMYLAN PHARMACEUTICALS INC2003-02-20ANDA074732_001, ANDA074732_002
5ANDA074858TAMOXIFEN CITRATETEVA PHARMACEUTICALS USA2003-02-20ANDA074858_001
6ANDA075740TAMOXIFEN CITRATETrueIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA2003-02-20ANDA075740_001, ANDA075740_002
7ANDA075797TAMOXIFEN CITRATETEVA PHARMACEUTICALS USA INC2003-02-20ANDA075797_001
8ANDA076027TAMOXIFEN CITRATETrueROXANE LABORATORIES INC2003-02-20ANDA076027_001, ANDA076027_002
9ANDA076179TAMOXIFEN CITRATEACTAVIS LABORATORIES FL INC2003-02-20ANDA076179_001, ANDA076179_002
10ANDA076398TAMOXIFEN CITRATETrueAEGIS PHARMACEUTICALS INC2003-03-31ANDA076398_001, ANDA076398_002
11ANDA090878TAMOXIFEN CITRATEAPOTEX INC2011-09-23ANDA090878_001, ANDA090878_002
12NDA017970NOLVADEXTrueASTRAZENECA PHARMACEUTICALS LPNDA017970_001, NDA017970_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA070929_001RXTAMOXIFEN CITRATE (EQ 10MG BASE)ORALTABLETFalseAB2003-02-20TAMOXIFEN CITRATE
2ANDA070929_002RXTAMOXIFEN CITRATE (EQ 20MG BASE)ORALTABLETFalseAB2003-02-20TAMOXIFEN CITRATE
3ANDA074504_001discontinuedTAMOXIFEN CITRATE (EQ 10MG BASE)ORALTABLETFalse2003-04-28TAMOXIFEN CITRATE
4ANDA074504_002discontinuedTAMOXIFEN CITRATE (EQ 20MG BASE)ORALTABLETFalse2003-04-28TAMOXIFEN CITRATE
5ANDA074539_001discontinuedTAMOXIFEN CITRATE (EQ 10MG BASE)ORALTABLETFalse2003-03-31TAMOXIFEN CITRATE
6ANDA074732_001RXTAMOXIFEN CITRATE (EQ 20MG BASE)ORALTABLETFalseAB2003-02-20TAMOXIFEN CITRATE
7ANDA074732_002RXTAMOXIFEN CITRATE (EQ 10MG BASE)ORALTABLETFalseAB2003-02-20TAMOXIFEN CITRATE
8ANDA074858_001RXTAMOXIFEN CITRATE (EQ 20MG BASE)ORALTABLETTrueAB2003-02-20TAMOXIFEN CITRATE
9ANDA075740_001discontinuedTAMOXIFEN CITRATE (EQ 10MG BASE)ORALTABLETFalse2003-02-20TAMOXIFEN CITRATE
10ANDA075740_002discontinuedTAMOXIFEN CITRATE (EQ 20MG BASE)ORALTABLETFalse2003-02-20TAMOXIFEN CITRATE
11ANDA075797_001RXTAMOXIFEN CITRATE (EQ 10MG BASE)ORALTABLETFalseAB2003-02-20TAMOXIFEN CITRATE
12ANDA076027_001discontinuedTAMOXIFEN CITRATE (EQ 10MG BASE)ORALTABLETFalse2003-02-20TAMOXIFEN CITRATE
13ANDA076027_002discontinuedTAMOXIFEN CITRATE (EQ 20MG BASE)ORALTABLETFalse2003-02-20TAMOXIFEN CITRATE
14ANDA076179_001RXTAMOXIFEN CITRATE (EQ 10MG BASE)ORALTABLETFalseAB2003-02-20TAMOXIFEN CITRATE
15ANDA076179_002RXTAMOXIFEN CITRATE (EQ 20MG BASE)ORALTABLETFalseAB2003-02-20TAMOXIFEN CITRATE
16ANDA076398_001discontinuedTAMOXIFEN CITRATE (EQ 10MG BASE)ORALTABLETFalse2003-03-31TAMOXIFEN CITRATE
17ANDA076398_002discontinuedTAMOXIFEN CITRATE (EQ 20MG BASE)ORALTABLETFalse2003-03-31TAMOXIFEN CITRATE
18ANDA090878_001RXTAMOXIFEN CITRATE (EQ 10MG BASE)ORALTABLETFalseAB2011-09-23TAMOXIFEN CITRATE
19ANDA090878_002RXTAMOXIFEN CITRATE (EQ 20MG BASE)ORALTABLETFalseAB2011-09-23TAMOXIFEN CITRATE
20NDA017970_001discontinuedTAMOXIFEN CITRATE (EQ 10MG BASE)ORALTABLETFalseNOLVADEX
21NDA017970_002discontinuedTAMOXIFEN CITRATE (EQ 20MG BASE)ORALTABLETFalse1994-03-21NOLVADEX

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1151ce76c-2d44-4c82-850d-ab213bea4d6b (view SPL)TAMOXIFEN CITRATE TABLETS USP, 10 mg and 20 mg (base) Rx onlyprescriptionHuman PrescriptionMckesson Packaging Services A Business Unit Of Mckesson CorporationREPACK2014-02-052637390269
22720c127-ec86-42ea-97e7-88dd6a195cdb (view SPL)TAMOXIFEN CITRATE TABLETS, USPprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2011-07-011636294413
3407a372d-4448-4d53-afd4-eb0e74bbc336 (view SPL)TAMOXIFEN CITRATE TABLETS USP, 10 mg and 20 mg (base)07840782Rx onlyprescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2012-06-297000930782, 000930784
461c988cc-a5bf-4cd2-81fd-4442a940622f (view SPL)TAMOXIFEN CITRATE TABLETS USP, 10 mg and 20 mg (base)Rx onlyprescriptionHuman PrescriptionKaiser Foundations Hospitalsrepack2014-03-311001791952
57ee3d3d2-85d1-4018-8e70-5ed8a64ae1f0 (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2013-04-095003780144, 003780274
686dcde0e-347c-49e1-8b38-ad106a25c9af (view SPL)TAMOXIFEN CITRATE TABLETS USP, 10 mg and 20 mg (base)07840782Rx onlyprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2010-01-132548683004, 548684287
79b8a4211-120f-4981-ad69-928accb97637 (view SPL)TAMOXIFEN CITRATE TABLETS, USPprescriptionHuman PrescriptionWatson Laboratories, Inc.ANALYSIS, MANUFACTURE2011-08-151005912472, 005912473
8f5ffe9dd-f76d-4aab-9473-81e33b26710b (view SPL)TAMOXIFEN CITRATE TABLETS, USPprescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-03-311680840924, 680840935

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII