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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020753
Company: PFIZER

Patient Information Sheet

Products on NDA 020753

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AROMASIN	EXEMESTANE	25MG	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020753

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
11/17/2021	SUPPL-22	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020753s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020753Orig1s022ltr.pdf
05/18/2018	SUPPL-20	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020753s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020753Orig1s020ltr.pdf
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.

Labels for NDA 020753

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/17/2021	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020753s022lbl.pdf
11/17/2021	SUPPL-22	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020753s022lbl.pdf
05/18/2018	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020753s020lbl.pdf
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

Therapeutic Equivalents for NDA 020753

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	PFIZER
EXEMESTANE	EXEMESTANE	25MG	TABLET;ORAL	Prescription	No	AB	211031	BRECKENRIDGE
EXEMESTANE	EXEMESTANE	25MG	TABLET;ORAL	Prescription	No	AB	210323	CIPLA
EXEMESTANE	EXEMESTANE	25MG	TABLET;ORAL	Prescription	No	AB	216454	EUGIA PHARMA
EXEMESTANE	EXEMESTANE	25MG	TABLET;ORAL	Prescription	No	AB	077431	HIKMA
EXEMESTANE	EXEMESTANE	25MG	TABLET;ORAL	Prescription	No	AB	213547	QILU
EXEMESTANE	EXEMESTANE	25MG	TABLET;ORAL	Prescription	No	AB	203315	RISING
EXEMESTANE	EXEMESTANE	25MG	TABLET;ORAL	Prescription	No	AB	209208	UPSHER SMITH LABS
EXEMESTANE	EXEMESTANE	25MG	TABLET;ORAL	Prescription	No	AB	202602	ZYDUS PHARMS

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