Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 020753
Company: PHARMACIA AND UPJOHN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AROMASIN EXEMESTANE 25MG TABLET;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/21/1999 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20753LBL.PDF https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20753LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-753_Aromasin.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/25/2016 SUPPL-18 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020753s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020753Orig1s018ltr.pdf
07/28/2014 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

05/02/2014 SUPPL-16 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020753s015s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020753Orig1s015,s016ltr.pdf
05/02/2014 SUPPL-15 Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020753s015s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020753Orig1s015,s016ltr.pdf
02/15/2013 SUPPL-14 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020753s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020753Orig1s014ltr.pdf
03/25/2011 SUPPL-12 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020753s009s011s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020753s009,s011s012ltr.pdf
03/25/2011 SUPPL-11 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020753s009s011s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020753s009,s011s012ltr.pdf
03/25/2011 SUPPL-9 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020753s009s011s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020753s009,s011s012ltr.pdf
12/24/2008 SUPPL-7 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020753s007ltr.pdf
10/05/2005 SUPPL-6 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020753s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020753s006ltr.pdf
09/23/2004 SUPPL-5 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20753s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20753s005ltr.pdf
11/13/2003 SUPPL-3 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20753slr003_aromasin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20753slr003ltr.pdf
04/04/2001 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

04/04/2001 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/25/2016 SUPPL-18 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020753s018lbl.pdf
05/02/2014 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020753s015s016lbl.pdf
05/02/2014 SUPPL-15 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020753s015s016lbl.pdf
02/15/2013 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020753s014lbl.pdf
03/25/2011 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020753s009s011s012lbl.pdf
03/25/2011 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020753s009s011s012lbl.pdf
03/25/2011 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020753s009s011s012lbl.pdf
10/05/2005 SUPPL-6 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020753s006lbl.pdf
09/23/2004 SUPPL-5 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20753s005lbl.pdf
11/13/2003 SUPPL-3 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20753slr003_aromasin_lbl.pdf
10/21/1999 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20753LBL.PDF

AROMASIN

TABLET;ORAL; 25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AROMASIN EXEMESTANE 25MG TABLET;ORAL Prescription Yes AB 020753 PHARMACIA AND UPJOHN
EXEMESTANE EXEMESTANE 25MG TABLET;ORAL Prescription No AB 200898 ALVOGEN MALTA
EXEMESTANE EXEMESTANE 25MG TABLET;ORAL Prescription No AB 203315 MYLAN PHARMS INC
EXEMESTANE EXEMESTANE 25MG TABLET;ORAL Prescription No AB 209208 UPSHER-SMITH LABS
EXEMESTANE EXEMESTANE 25MG TABLET;ORAL Prescription No AB 077431 WEST-WARD PHARMS INT

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English