Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022473
Company: VIATRIS
Company: VIATRIS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
REVATIO | SILDENAFIL CITRATE | EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | AP | 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 |
---|---|---|---|---|---|---|---|
11/18/2009 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022473lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022473s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022473_revatio_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022473s000_SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/03/2023 | SUPPL-16 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/203109s016,022473s176lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/203109Orig1s016;022473Orig1s016ltr.pdf | |
01/17/2019 | SUPPL-12 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022473s012,203109s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022473Orig1s012,203109Orig1s012ltr.pdf | |
07/31/2017 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203109s011,022473s011,021845s020lbl.pdf | |
04/27/2015 | SUPPL-10 | 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 | |
08/21/2014 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/06/2014 | SUPPL-7 | 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-6 | 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 | |
01/31/2014 | SUPPL-5 | Labeling-Patient 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 | |
03/11/2014 | SUPPL-4 | Labeling-Package Insert, Labeling-Patient 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 | |
08/30/2012 | SUPPL-3 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022473s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022473Orig1s003ltr.pdf | |
11/19/2010 | SUPPL-1 | Labeling-Patient 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 |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
03/03/2023 | SUPPL-16 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/203109s016,022473s176lbl.pdf | |
01/17/2019 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022473s012,203109s012lbl.pdf | |
07/31/2017 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203109s011,022473s011,021845s020lbl.pdf | |
04/27/2015 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021845s016,022473s010,203109s009lbl.pdf | |
03/11/2014 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021845s011,022473s004,0203109s002lbl.pdf | |
03/11/2014 | SUPPL-4 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021845s011,022473s004,0203109s002lbl.pdf | |
03/06/2014 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021845s014,022473s007,203109s005lbl.pdf | |
01/31/2014 | SUPPL-6 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021845s012s013,022473s005s006,203109s003s004lbl.pdf | |
01/31/2014 | SUPPL-5 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021845s012s013,022473s005s006,203109s003s004lbl.pdf | |
08/30/2012 | SUPPL-3 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022473s003lbl.pdf | |
11/19/2010 | SUPPL-1 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021845s007,022473s001lbl.pdf | |
11/18/2009 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022473lbl.pdf |
REVATIO
SOLUTION;INTRAVENOUS; EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
REVATIO | SILDENAFIL CITRATE | EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 022473 | VIATRIS |
SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 203988 | EUGIA PHARMA |