Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 207027
Company: NOVARTIS
Company: NOVARTIS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PROMACTA KIT | ELTROMBOPAG OLAMINE | EQ 25MG ACID/PACKET | FOR SUSPENSION;ORAL | Prescription | AB | Yes | Yes |
PROMACTA KIT | ELTROMBOPAG OLAMINE | EQ 12.5MG ACID/PACKET | FOR SUSPENSION;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 |
---|---|---|---|---|---|---|---|
08/24/2015 | ORIG-1 | Approval | Type 3 - New Dosage Form and Type 4 - New Combination | PRIORITY; Orphan |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207027s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207027Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207027Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207027Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/09/2023 | SUPPL-17 | 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 | |
03/31/2022 | SUPPL-15 | 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-14 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207027s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/207027Orig1s014ltr.pdf | |
10/08/2020 | SUPPL-13 | Manufacturing (CMC)-Facility |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207027Orig1s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/207027Orig1s013ltr.pdf | |
04/29/2020 | SUPPL-10 | Labeling-Medication Guide, Labeling-Package Insert |
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 | |
04/24/2019 | SUPPL-8 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207027s008lbl.pdf | |
09/27/2018 | SUPPL-6 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207027s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207027Orig1s006ltr.pdf | |
07/24/2018 | SUPPL-5 | 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 | |
05/25/2018 | SUPPL-4 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207027s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207027Orig1s004ltr.pdf | |
07/05/2017 | SUPPL-3 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207027s003lbl.pdf | |
03/09/2017 | SUPPL-2 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207027s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022291Orig1s017,207027Orig1s002ltr.pdf | |
10/12/2016 | SUPPL-1 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022291s016,207027s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207027Orig1s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
03/09/2023 | SUPPL-17 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022291s037,207027s017lbl.pdf | |
03/31/2022 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022291s033,207027s015lbl.pdf | |
02/03/2021 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207027s014lbl.pdf | |
10/08/2020 | SUPPL-13 | Manufacturing (CMC)-Facility | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207027Orig1s013lbl.pdf | |
04/29/2020 | SUPPL-10 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022291s027,207027s010lbl.pdf | |
04/29/2020 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022291s027,207027s010lbl.pdf | |
04/24/2019 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207027s008lbl.pdf | |
09/27/2018 | SUPPL-6 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207027s006lbl.pdf | |
09/27/2018 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207027s006lbl.pdf | |
07/24/2018 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022291s020,207027s005lbl.pdf | |
05/25/2018 | SUPPL-4 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207027s004lbl.pdf | |
05/25/2018 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207027s004lbl.pdf | |
07/05/2017 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207027s003lbl.pdf | |
03/09/2017 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207027s002lbl.pdf | |
10/12/2016 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022291s016,207027s001lbl.pdf | |
08/24/2015 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207027s000lbl.pdf |
PROMACTA KIT
FOR SUSPENSION;ORAL; EQ 25MG ACID/PACKET
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ELTROMBOPAG OLAMINE | ELTROMBOPAG OLAMINE | EQ 25MG ACID/PACKET | FOR SUSPENSION;ORAL | Prescription | No | AB | 216620 | ANNORA PHARMA |
PROMACTA KIT | ELTROMBOPAG OLAMINE | EQ 25MG ACID/PACKET | FOR SUSPENSION;ORAL | Prescription | Yes | AB | 207027 | NOVARTIS |
FOR SUSPENSION;ORAL; EQ 12.5MG ACID/PACKET
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ELTROMBOPAG OLAMINE | ELTROMBOPAG OLAMINE | EQ 12.5MG ACID/PACKET | FOR SUSPENSION;ORAL | Prescription | No | AB | 216620 | ANNORA PHARMA |
PROMACTA KIT | ELTROMBOPAG OLAMINE | EQ 12.5MG ACID/PACKET | FOR SUSPENSION;ORAL | Prescription | Yes | AB | 207027 | NOVARTIS |