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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 207027
Company: NOVARTIS

Medication Guide

Summary Review

Products on NDA 207027

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 207027

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-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
04/24/2019	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207027s008lbl.pdf
09/27/2018	SUPPL-6	Labeling-Package Insert, Labeling-Medication Guide	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

Labels for NDA 207027

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-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022291s027,207027s010lbl.pdf
04/29/2020	SUPPL-10	Labeling-Medication Guide	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-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207027s006lbl.pdf
09/27/2018	SUPPL-6	Labeling-Medication Guide	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

Therapeutic Equivalents for NDA 207027

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

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