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FDA NDA · NDA207027

PROMACTA

eltrombopag olamine

Sponsor: NOVARTIS

APPLICATION
NDA207027
TYPE
NDA
ORIGINAL APPROVAL
2015-08-24
LATEST ACTION
2025-06-06
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Prescription

Products

PROMACTA KIT · ReferencePrescription
ELTROMBOPAG OLAMINE EQ 25MG ACID/PACKET · FOR SUSPENSION · ORAL
PROMACTA KIT · ReferencePrescription
ELTROMBOPAG OLAMINE EQ 12.5MG ACID/PACKET · FOR SUSPENSION · ORAL

Approval history

2025-06-06Labeling · Supplement 20 · standard — Label ↗AP
2023-03-09Labeling · Supplement 17 · standard — Letter ↗AP
2022-03-31Labeling · Supplement 15 · standard — Letter ↗AP
2021-02-03Labeling · Supplement 14 · standard — Label ↗AP
2020-10-08Manufacturing (CMC) · Supplement 13 — Letter ↗AP
2020-04-29Labeling · Supplement 10 · standard — Letter ↗AP
2019-04-24Labeling · Supplement 8 · standard — Label ↗AP
2018-09-27Labeling · Supplement 6 · standard — Letter ↗AP
2018-07-24Labeling · Supplement 5 · standard — Label ↗AP
2018-05-25Labeling · Supplement 4 · standard — Letter ↗AP
2017-07-05Labeling · Supplement 3 · standard — Label ↗AP
2017-03-09Labeling · Supplement 2 · standard — Label ↗AP
2016-10-12Labeling · Supplement 1 · standard — Letter ↗AP
2015-08-24Type 3 - New Dosage Form and Type 4 - New Combination · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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