Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 207947
Company: ACTELION
Company: ACTELION
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
UPTRAVI | SELEXIPAG | 0.2MG | TABLET;ORAL | Prescription | AB | Yes | No |
UPTRAVI | SELEXIPAG | 0.4MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
UPTRAVI | SELEXIPAG | 0.6MG | TABLET;ORAL | Prescription | AB | Yes | No |
UPTRAVI | SELEXIPAG | 0.8MG | TABLET;ORAL | Prescription | AB | Yes | No |
UPTRAVI | SELEXIPAG | 1MG | TABLET;ORAL | Prescription | AB | Yes | No |
UPTRAVI | SELEXIPAG | 1.2MG | TABLET;ORAL | Prescription | AB | Yes | No |
UPTRAVI | SELEXIPAG | 1.4MG | TABLET;ORAL | Prescription | AB | Yes | No |
UPTRAVI | SELEXIPAG | 1.6MG | TABLET;ORAL | Prescription | AB | Yes | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
12/21/2015 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD; Orphan |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/2015/207947s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207947Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207947Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207947Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/19/2021 | SUPPL-10 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207947s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/207947Orig1s010ltr.pdf | |
10/25/2021 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207947s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/207947Orig1s009ltr.pdf | |
01/30/2021 | SUPPL-8 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207947s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/207947Orig1s008ltr.pdf | |
09/04/2019 | SUPPL-7 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207947s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/207947Orig1s007ltr.pdf | |
12/20/2017 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207947s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207947Orig1s005ltr.pdf | |
09/28/2017 | SUPPL-3 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207947s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207947Orig1s003ltr.pdf | |
07/21/2017 | SUPPL-1 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207947s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207947Orig1s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
10/25/2021 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207947s009lbl.pdf | |
08/19/2021 | SUPPL-10 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207947s010lbl.pdf | |
08/19/2021 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207947s010lbl.pdf | |
01/30/2021 | SUPPL-8 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207947s008lbl.pdf | |
09/04/2019 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207947s007lbl.pdf | |
12/20/2017 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207947s005lbl.pdf | |
09/28/2017 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207947s003lbl.pdf | |
07/21/2017 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207947s001lbl.pdf | |
12/21/2015 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/2015/207947s000lbl.pdf |
UPTRAVI
TABLET;ORAL; 0.2MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
SELEXIPAG | SELEXIPAG | 0.2MG | TABLET;ORAL | Prescription | No | AB | 214414 | ALEMBIC |
UPTRAVI | SELEXIPAG | 0.2MG | TABLET;ORAL | Prescription | Yes | AB | 207947 | ACTELION |
TABLET;ORAL; 0.4MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
SELEXIPAG | SELEXIPAG | 0.4MG | TABLET;ORAL | Prescription | No | AB | 214414 | ALEMBIC |
UPTRAVI | SELEXIPAG | 0.4MG | TABLET;ORAL | Prescription | Yes | AB | 207947 | ACTELION |
TABLET;ORAL; 0.6MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
SELEXIPAG | SELEXIPAG | 0.6MG | TABLET;ORAL | Prescription | No | AB | 214414 | ALEMBIC |
UPTRAVI | SELEXIPAG | 0.6MG | TABLET;ORAL | Prescription | Yes | AB | 207947 | ACTELION |
TABLET;ORAL; 0.8MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
SELEXIPAG | SELEXIPAG | 0.8MG | TABLET;ORAL | Prescription | No | AB | 214414 | ALEMBIC |
UPTRAVI | SELEXIPAG | 0.8MG | TABLET;ORAL | Prescription | Yes | AB | 207947 | ACTELION |
TABLET;ORAL; 1MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
UPTRAVI | SELEXIPAG | 1MG | TABLET;ORAL | Prescription | Yes | AB | 207947 | ACTELION |
TABLET;ORAL; 1.2MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
UPTRAVI | SELEXIPAG | 1.2MG | TABLET;ORAL | Prescription | Yes | AB | 207947 | ACTELION |
TABLET;ORAL; 1.4MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
SELEXIPAG | SELEXIPAG | 1.4MG | TABLET;ORAL | Prescription | No | AB | 214414 | ALEMBIC |
UPTRAVI | SELEXIPAG | 1.4MG | TABLET;ORAL | Prescription | Yes | AB | 207947 | ACTELION |
TABLET;ORAL; 1.6MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
SELEXIPAG | SELEXIPAG | 1.6MG | TABLET;ORAL | Prescription | No | AB | 214414 | ALEMBIC |
UPTRAVI | SELEXIPAG | 1.6MG | TABLET;ORAL | Prescription | Yes | AB | 207947 | ACTELION |