Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022291
Company: NOVARTIS
Company: NOVARTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROMACTA | ELTROMBOPAG OLAMINE | EQ 25MG ACID | TABLET;ORAL | Prescription | None | Yes | No |
| PROMACTA | ELTROMBOPAG OLAMINE | EQ 50MG ACID | TABLET;ORAL | Prescription | None | Yes | No |
| PROMACTA | ELTROMBOPAG OLAMINE | EQ 75MG ACID | TABLET;ORAL | Prescription | None | Yes | Yes |
| PROMACTA | ELTROMBOPAG OLAMINE | EQ 12.5MG ACID | TABLET;ORAL | Prescription | None | Yes | No |
| PROMACTA | ELTROMBOPAG OLAMINE | EQ 100MG ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 11/20/2008 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY; Orphan |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022291lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022291s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022291s000_TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022291s000_SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/06/2023 | SUPPL-38 | Manufacturing (CMC)-Facility |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022291Orig1s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022291Orig1s038ltr.pdf | |
| 03/09/2023 | SUPPL-37 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022291s037,207027s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022291Orig1s037;207027Orig1s017ltr.pdf | |
| 11/15/2022 | SUPPL-35 | Manufacturing (CMC)-Facility |
Label (PDF)
Letter (PDF) Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022291Orig1s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022291Orig1s035ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022291Orig1s035ltr.pdf | |
| 03/31/2022 | SUPPL-33 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022291s033,207027s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022291Orig1s033; 207027Orig1s015ltr.pdf | |
| 02/03/2021 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022291s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022291Orig1s031ltr.pdf | |
| 04/29/2020 | SUPPL-27 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022291s027,207027s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022291Orig1s027, 207027Orig1s010ltr.pdf | |
| 04/28/2020 | SUPPL-26 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022291Orig1s026ltr.pdf |
| 11/16/2018 | SUPPL-21 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022291s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022291Orig1s021ltr.pdf | |
| 07/24/2018 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022291s020,207027s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022291Orig1s020,207027Orig1s005Ltr.pdf | |
| 10/04/2017 | SUPPL-19 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022291s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022291s019ltr.pdf | |
| 07/05/2017 | SUPPL-18 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022291s018lbl.pdf | |
| 03/09/2017 | SUPPL-17 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022291s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022291Orig1s017,207027Orig1s002ltr.pdf | |
| 10/12/2016 | SUPPL-16 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022291s016,207027s001lbl.pdf | |
| 06/11/2015 | SUPPL-15 | Efficacy-Pediatric |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022291s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022291Orig1s015ltr.pdf | |
| 04/07/2015 | SUPPL-14 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022291s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022291Orig1s014ltr.pdf | |
| 07/16/2014 | SUPPL-13 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022291Orig1s013ltr.pdf |
| 08/26/2014 | SUPPL-12 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022291s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022291Orig1s012ltr.pdf | |
| 04/10/2014 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022291Orig1s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022291Orig1s011ltr.pdf | |
| 02/10/2014 | SUPPL-10 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022291s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022291Orig1s010ltr.pdf | |
| 11/16/2012 | SUPPL-8 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022291s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022291Orig1s008ltr.pdf | |
| 12/06/2011 | SUPPL-6 | REMS-Modified, Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022291s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022291s006ltr.pdf | |
| 03/05/2010 | SUPPL-3 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022291s003ltr.pdf |
| 02/25/2011 | SUPPL-1 | Efficacy-Accelerated Approval |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022291s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022291s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/06/2023 | SUPPL-38 | Manufacturing (CMC)-Facility | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022291Orig1s038lbl.pdf | |
| 03/09/2023 | SUPPL-37 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022291s037,207027s017lbl.pdf | |
| 11/15/2022 | SUPPL-35 | Manufacturing (CMC)-Facility | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022291Orig1s035lbl.pdf | |
| 03/31/2022 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022291s033,207027s015lbl.pdf | |
| 02/03/2021 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022291s031lbl.pdf | |
| 04/29/2020 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022291s027,207027s010lbl.pdf | |
| 04/29/2020 | SUPPL-27 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022291s027,207027s010lbl.pdf | |
| 11/16/2018 | SUPPL-21 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022291s021lbl.pdf | |
| 07/24/2018 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022291s020,207027s005lbl.pdf | |
| 10/04/2017 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022291s019lbl.pdf | |
| 07/05/2017 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022291s018lbl.pdf | |
| 03/09/2017 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022291s017lbl.pdf | |
| 10/12/2016 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022291s016,207027s001lbl.pdf | |
| 06/11/2015 | SUPPL-15 | Efficacy-Pediatric | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022291s015lbl.pdf | |
| 04/07/2015 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022291s014lbl.pdf | |
| 08/26/2014 | SUPPL-12 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022291s012lbl.pdf | |
| 04/10/2014 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022291Orig1s011lbl.pdf | |
| 02/10/2014 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022291s010lbl.pdf | |
| 02/10/2014 | SUPPL-10 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022291s010lbl.pdf | |
| 11/16/2012 | SUPPL-8 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022291s008lbl.pdf | |
| 12/06/2011 | SUPPL-6 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022291s006lbl.pdf | |
| 12/06/2011 | SUPPL-6 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022291s006lbl.pdf | |
| 02/25/2011 | SUPPL-1 | Efficacy-Accelerated Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022291s001lbl.pdf | |
| 11/20/2008 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022291lbl.pdf |