Documents
Application Sponsors
| NDA 020753 | PHARMACIA AND UPJOHN | |
Marketing Status
Application Products
| 001 | TABLET;ORAL | 25MG | 1 | AROMASIN | EXEMESTANE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1999-10-21 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 2001-04-04 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2003-11-13 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2004-09-23 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 6 | AP | 2005-10-05 | UNKNOWN |
| LABELING; Labeling | SUPPL | 7 | AP | 2008-12-24 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2011-03-25 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2011-03-25 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2011-03-25 | UNKNOWN |
| LABELING; Labeling | SUPPL | 14 | AP | 2013-02-15 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2014-05-02 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2014-05-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 2014-07-28 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 18 | AP | 2016-07-25 | STANDARD |
| LABELING; Labeling | SUPPL | 20 | AP | 2018-05-18 | STANDARD |
| LABELING; Labeling | SUPPL | 22 | AP | 2021-11-17 | STANDARD |
Submissions Property Types
| ORIG | 1 | Orphan | 5 |
| SUPPL | 2 | Null | 14 |
| SUPPL | 9 | Null | 7 |
| SUPPL | 11 | Null | 7 |
| SUPPL | 12 | Null | 7 |
| SUPPL | 14 | Null | 7 |
| SUPPL | 15 | Null | 31 |
| SUPPL | 16 | Null | 15 |
| SUPPL | 17 | Null | 14 |
| SUPPL | 18 | Null | 7 |
| SUPPL | 20 | Null | 6 |
| SUPPL | 22 | Null | 15 |
TE Codes
CDER Filings
PFIZER
cder:Array
(
[0] => Array
(
[ApplNo] => 20753
[companyName] => PFIZER
[docInserts] => ["",""]
[products] => [{"drugName":"AROMASIN","activeIngredients":"EXEMESTANE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"11\/17\/2021","submission":"SUPPL-22","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/020753s022lbl.pdf\"}]","notes":""},{"actionDate":"11\/17\/2021","submission":"SUPPL-22","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/020753s022lbl.pdf\"}]","notes":""},{"actionDate":"05\/18\/2018","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020753s020lbl.pdf\"}]","notes":""},{"actionDate":"07\/25\/2016","submission":"SUPPL-18","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020753s018lbl.pdf\"}]","notes":""},{"actionDate":"05\/02\/2014","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020753s015s016lbl.pdf\"}]","notes":""},{"actionDate":"05\/02\/2014","submission":"SUPPL-15","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020753s015s016lbl.pdf\"}]","notes":""},{"actionDate":"02\/15\/2013","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/020753s014lbl.pdf\"}]","notes":""},{"actionDate":"03\/25\/2011","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020753s009s011s012lbl.pdf\"}]","notes":""},{"actionDate":"03\/25\/2011","submission":"SUPPL-11","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020753s009s011s012lbl.pdf\"}]","notes":""},{"actionDate":"03\/25\/2011","submission":"SUPPL-9","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020753s009s011s012lbl.pdf\"}]","notes":""},{"actionDate":"10\/05\/2005","submission":"SUPPL-6","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/020753s006lbl.pdf\"}]","notes":""},{"actionDate":"09\/23\/2004","submission":"SUPPL-5","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/20753s005lbl.pdf\"}]","notes":""},{"actionDate":"11\/13\/2003","submission":"SUPPL-3","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/20753slr003_aromasin_lbl.pdf\"}]","notes":""},{"actionDate":"10\/21\/1999","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1999\\\/20753LBL.PDF\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"AROMASIN","submission":"EXEMESTANE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2021-11-17
)
)