Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021845
Company: PFIZER
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
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.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

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 PFIZER
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 HEBEI CHANGSHAN
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 203814 MACLEODS PHARMS LTD
SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 20MG BASE TABLET;ORAL Prescription No AB 201150 MYLAN PHARMS INC
SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 20MG BASE TABLET;ORAL Prescription No AB 204883 RUBICON
SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 20MG BASE TABLET;ORAL Prescription No AB 078380 TEVA PHARMS
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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