Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021845
Company: VIATRIS
Company: VIATRIS
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 |
---|---|---|---|---|---|
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 |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
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 |
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 | 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 |