Eltrombopag Olamine

Treats thrombocytopenia. ANDA 206788, held by Hetero Labs Ltd V. Eltrombopag Olamine.

As of Nov 15, 2026, ANDA 206788 (Eltrombopag Olamine), held by Hetero Labs Ltd V, was first approved by FDA on Jan 17, 2025, with 0 approved supplements and 0 published complete response letters.

First approved: Jan 17, 2025
Review: Standard
Supplements approved: 0
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Eltrombopag tablet is a thrombopoietin receptor agonist indicated:

for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Eltrombopag tablets should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding.
for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first

Date	Submission	Status	Documents
Jan 17, 2025	Original application	Approved	Letter

Products

4 strengths and forms


Eltrombopag OlamineEQ 12.5MG ACID · tablet;oral	Eltrombopag Olamine	Rx
Eltrombopag OlamineEQ 25MG ACID · tablet;oral	Eltrombopag Olamine	Rx
Eltrombopag OlamineEQ 50MG ACID · tablet;oral	Eltrombopag Olamine	Rx
Eltrombopag OlamineEQ 75MG ACID · tablet;oral	Eltrombopag Olamine	Rx

Identifiers

Application: ANDA 206788
Drugs@FDA: Overview at FDA
Company: Hetero Labs Ltd

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters