FDA.reportPublic FDA data

Application 020753

Type
NDA
Sponsor
PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AROMASINEXEMESTANETABLET;ORAL25MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0009-7663AromasinexemestanePharmacia & Upjohn Company LLCNDACurrent
0009-7663AromasinexemestanePharmacia and Upjohn Company LLCNDACurrent
0009-7663AromasinexemestanePharmacia & Upjohn Company LLCNDACurrent
0009-7663AromasinexemestanePharmacia & Upjohn Company LLCNDACurrent
59762-2858EXEMESTANEExemestaneGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-2858EXEMESTANEExemestaneGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-2858EXEMESTANEExemestaneGreenstone LLCNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80622SUPPL 2024-12-18
80601SUPPL 2024-12-17
69356SUPPL2021-11-18
69342SUPPL2021-11-18
54284SUPPL2018-05-22
54276SUPPL2018-05-21
13350SUPPL2016-07-27
25705SUPPL2016-07-26
35273SUPPL2014-05-06
25704SUPPL2014-05-06
13349SUPPL2014-05-06
3267SUPPL2014-05-06
13348SUPPL2013-02-20
3266SUPPL2013-02-20
25703SUPPL2011-03-28
25702SUPPL2011-03-28
13347SUPPL2011-03-28
13346SUPPL2011-03-28
13345SUPPL2011-03-28
3265SUPPL2011-03-28
24138SUPPL2009-01-02
25701SUPPL2008-12-30
3264SUPPL2005-10-11
13344SUPPL2005-10-07
25700SUPPL2004-09-29
13343SUPPL2004-09-29
20900ORIG2004-05-27
13342SUPPL2003-12-02
3263SUPPL2003-11-25
13341ORIG1999-10-21
3262ORIG1999-10-21