Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020180
Company: ORGANON

• Other Important Information from FDA

Products on NDA 20180

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PROSCAR	FINASTERIDE	5MG	TABLET;ORAL	Prescription	AB	Yes	Yes

Labels for NDA 020180

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/18/2026	SUPPL-50	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/020180s050lbl.pdf
03/18/2026	SUPPL-50	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/020180s050lbl.pdf
08/25/2021	SUPPL-49	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020180s049lbl.pdf
06/15/2021	SUPPL-47	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020180s047lbl.pdf
06/15/2021	SUPPL-47	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020180s047lbl.pdf
04/13/2021	SUPPL-48	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020180s048lbl.pdf
03/11/2014	SUPPL-44	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020180s044lbl.pdf
01/16/2013	SUPPL-43	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020180s043lbl.pdf
04/11/2012	SUPPL-42	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020180s040s041s042lbl.pdf
04/11/2012	SUPPL-41	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020180s040s041s042lbl.pdf
04/11/2012	SUPPL-40	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020180s040s041s042lbl.pdf
06/09/2011	SUPPL-39	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020180s039lbl.pdf
10/04/2010	SUPPL-37	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020180s037lbl.pdf
03/23/2010	SUPPL-33	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020180s033lbl.pdf
04/23/2004	SUPPL-29	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20180slr029_proscar_lbl.pdf
04/12/2004	SUPPL-26	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020180s026lbl.pdf
09/09/2003	SUPPL-27	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20180slr027_proscar_lbl.pdf