Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020895
Company: VIATRIS

• Other Important Information from FDA

Products on NDA 20895

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VIAGRA	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET;ORAL	Prescription	AB	Yes	No
VIAGRA	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET;ORAL	Prescription	AB	Yes	No
VIAGRA	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET;ORAL	Prescription	AB	Yes	Yes

Labels for NDA 020895

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/14/2017	SUPPL-48	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020895s048lbl.pdf
08/17/2017	SUPPL-49	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020895s049lbl.pdf
09/16/2015	SUPPL-45	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020895s045lbl.pdf
03/26/2015	SUPPL-44	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020895s044lbl.pdf
03/11/2014	SUPPL-42	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/20895s039s042lbl.pdf
03/11/2014	SUPPL-39	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/20895s039s042lbl.pdf
01/31/2011	SUPPL-36	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020895s036lbl.pdf
01/11/2010	SUPPL-33	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020895s033lbl.pdf
02/25/2008	SUPPL-26	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020895s026lbl.pdf
10/18/2007	SUPPL-27	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020895s027lbl.pdf
10/06/2006	SUPPL-23	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020895s023lbl.pdf
06/26/2006	SUPPL-20	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020895s20lbl.pdf
07/08/2005	SUPPL-21	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020895s021lbl.pdf
09/19/2002	SUPPL-18	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20895s11s15s18lbl.pdf
09/19/2002	SUPPL-15	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20895s11s15s18lbl.pdf
09/19/2002	SUPPL-11	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20895s11s15s18lbl.pdf
03/27/1998	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/viagralabel2.pdf