exemestane Oral Tablet

Brand(s)
Aromasin
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Pharmacia And Upjohn Company (2014-05-21)
Oldest Current Product
1999-10-21
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL TABLET\EXEMESTANE
FDAOB
ORAL\TABLET\EXEMESTANE
SPL Active
ORAL\TABLET, FILM COATED\EXEMESTANE
ORAL\TABLET, SUGAR COATED\EXEMESTANE
ORAL\TABLET\EXEMESTANE
SPL Moiety
ORAL\TABLET, FILM COATED\EXEMESTANE
ORAL\TABLET, SUGAR COATED\EXEMESTANE
ORAL\TABLET\EXEMESTANE

product(s) by strength(s)

exemestane 25 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000097663AromasinNDAPharmacia And Upjohn Company1999-10-21EXEMESTANEORALTABLETNDA020753cf066b7a-032a-416c-8d40-15ba581423e3

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540080ANDARoxane Laboratories, Inc2011-04-01EXEMESTANEORALTABLET, FILM COATEDANDA0774312ecdb646-4d0f-4d1b-ac6a-9cb5deb9ac0d
2477810108ANDAAlvogen, Inc.2014-07-25EXEMESTANEORALTABLETANDA20089861d86c55-9946-273f-4f22-42d3fc33d143
3597622858NDA AUTHORIZED GENERICGreenstone Llc2011-04-01EXEMESTANEORALTABLET, SUGAR COATEDNDA02075369abd0ff-b200-4d1a-b14a-80e980a8e781

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685261AromasinNDAPhysicians Total Care, Inc.2005-06-29EXEMESTANEORALTABLET000097663NDA020753f0b31daa-0792-43d5-af08-8b6a864dc90a
2606870132ANDAAmerican Health Packaging2015-03-31EXEMESTANEORALTABLET477810108ANDA20089864d97d3e-5356-4627-b3b1-1716fc32f72d

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA077431EXEMESTANEROXANE LABORATORIES INC2011-04-01ANDA077431_001
2ANDA200898EXEMESTANEALVOGEN INC2014-07-28ANDA200898_001
3NDA020753AROMASINPHARMACIA AND UPJOHN CO1999-10-21NDA020753_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA077431_001RXEXEMESTANE (25MG)ORALTABLETFalseAB2011-04-01EXEMESTANE
2ANDA200898_001RXEXEMESTANE (25MG)ORALTABLETFalseAB2014-07-28EXEMESTANE
3NDA020753_001RXEXEMESTANE (25MG)ORALTABLETTrueAB1999-10-21AROMASIN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
12ecdb646-4d0f-4d1b-ac6a-9cb5deb9ac0d (view SPL)These highlights do not include all the information needed to use EXEMESTANE tablets safely and effectively. See full prescribing information for EXEMESTANE tablets. EXEMESTANE tablets, oralInitial U.S. Approval: 1999prescriptionHuman PrescriptionRoxane Laboratories, IncMANUFACTURE2015-07-285000540080
261d86c55-9946-273f-4f22-42d3fc33d143 (view SPL)These highlights do not include all the information needed to use exemestane safely and effectively. See full prescribing information for exemestane. Exemestane tablets, oral Initial U.S. Approval: 1999prescriptionHuman PrescriptionAlvogen, Inc.analysis, manufacture, pack2014-07-251477810108
364d97d3e-5356-4627-b3b1-1716fc32f72d (view SPL)These highlights do not include all the information needed to use exemestane safely and effectively. See full prescribing information for exemestane.Exemestane tablets, oralInitial U.S. Approval: 1999prescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-04-131606870132
469abd0ff-b200-4d1a-b14a-80e980a8e781 (view SPL)These highlights do not include all the information needed to use EXEMESTANE safely and effectively. See full prescribing information for EXEMESTANE. EXEMESTANE tablets, oral Initial U.S. Approval: 1999prescriptionHuman PrescriptionGreenstone LlcAPI MANUFACTURE, MANUFACTURE, PACK2014-01-138597622858
5cf066b7a-032a-416c-8d40-15ba581423e3 (view SPL)These highlights do not include all the information needed to use AROMASIN safely and effectively. See full prescribing information for AROMASIN. AROMASIN (exemestane) tablets, oralInitial U.S. Approval: 1999prescriptionHuman PrescriptionPharmacia And Upjohn CompanyANALYSIS, API MANUFACTURE, MANUFACTURE2014-05-2112000097663
6f0b31daa-0792-43d5-af08-8b6a864dc90a (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2010-01-041548685261

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