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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 20753

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

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

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