Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 207027
Company: NOVARTIS PHARMS CORP
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 None Yes Yes
PROMACTA KIT ELTROMBOPAG OLAMINE EQ 12.5MG ACID/PACKET FOR SUSPENSION;ORAL Prescription 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
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
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-Package Insert, Labeling-Container/Carton Labels 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
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-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207027s004lbl.pdf
05/25/2018 SUPPL-4 Labeling-Container/Carton Labels 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

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