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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021845
Company: VIATRIS

Patient Information Sheet

Other Important Information from FDA

Products on NDA 021845

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
REVATIO	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021845

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/03/2005	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021845lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021845ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021845s000_RevatioTOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/16/2024	SUPPL-28	Manufacturing (CMC)-Packaging	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/021845Orig1s028,022473Orig1s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/021845Orig1s028,022473Orig1s019ltr.pdf
01/31/2023	SUPPL-25	Efficacy-New Indication	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021845s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021845Orig1s025ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/021845Orig1s025.pdf
07/31/2017	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021845s20_022473s11_203109s11lbl.pdf
02/01/2018	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021845s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021845Orig1s018ltr.pdf
04/27/2015	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021845s016,022473s010,203109s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021845Orig1s016,022473Orig1s010,203109Origs009ltr.pdf
03/06/2014	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021845s014,022473s007,203109s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021845Orig1s014,022473Orig1s007,203109Orig1s005ltr.pdf
01/31/2014	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021845s012s013,022473s005s006,203109s003s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021845Orig1s012,013;022473Orig1s005,006;203109Orig1s003,004ltr.pdf
01/31/2014	SUPPL-12	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021845s012s013,022473s005s006,203109s003s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021845Orig1s012,013;022473Orig1s005,006;203109Orig1s003,004ltr.pdf
03/11/2014	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021845s011,022473s004,0203109s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021845Orig1s011,022473Orig1s004,203109Origs002ltr.pdf
02/03/2015	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
08/30/2012	SUPPL-8	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021845s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021845Orig1s008ltr.pdf
11/19/2010	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021845s007,022473s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021845s007,022473s001ltr.pdf
05/07/2009	SUPPL-6	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021845s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021845s006ltr.pdf
02/17/2009	SUPPL-5	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021845s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021845s005ltr.pdf
12/18/2007	SUPPL-4	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021845s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021845s004ltr.pdf
07/19/2006	SUPPL-3	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021845s003_ltr.pdf
07/27/2006	SUPPL-2	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021845s002ltr.pdf
11/03/2005	SUPPL-1	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021845s001ltr.pdf

Labels for NDA 021845

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/16/2024	SUPPL-28	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/021845Orig1s028,022473Orig1s019lbl.pdf
01/31/2023	SUPPL-25	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021845s025lbl.pdf
02/01/2018	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021845s018lbl.pdf
07/31/2017	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021845s20_022473s11_203109s11lbl.pdf
04/27/2015	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021845s016,022473s010,203109s009lbl.pdf
03/11/2014	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021845s011,022473s004,0203109s002lbl.pdf
03/06/2014	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021845s014,022473s007,203109s005lbl.pdf
01/31/2014	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021845s012s013,022473s005s006,203109s003s004lbl.pdf
01/31/2014	SUPPL-12	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021845s012s013,022473s005s006,203109s003s004lbl.pdf
08/30/2012	SUPPL-8	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021845s008lbl.pdf
11/19/2010	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021845s007,022473s001lbl.pdf
05/07/2009	SUPPL-6	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021845s006lbl.pdf
02/17/2009	SUPPL-5	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021845s005lbl.pdf
12/18/2007	SUPPL-4	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021845s004lbl.pdf
06/03/2005	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021845lbl.pdf

Therapeutic Equivalents for NDA 021845

REVATIO

TABLET;ORAL; EQ 20MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
REVATIO	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET;ORAL	Prescription	Yes	AB	021845	VIATRIS
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	210394	AJANTA PHARMA LTD
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	202025	AMNEAL PHARMS
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	203963	AUROBINDO PHARMA LTD
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	202598	CHARTWELL RX
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	203623	HETERO LABS LTD V
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	202954	JUBILANT GENERICS
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	203814	MACLEODS PHARMS LTD
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	204883	RUBICON RESEARCH
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	091479	TORRENT PHARMS LTD
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	202503	WATSON LABS INC

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