Treats thrombocytopenia. ANDA 209938, held by Teva Pharms USA. Eltrombopag Olamine.
As of Nov 15, 2026, ANDA 209938 (Eltrombopag Olamine), held by Teva Pharms USA, was first approved by FDA on Jul 13, 2026, with 0 approved supplements and 0 published complete response letters.
Eltrombopag tablets are a thrombopoietin receptor agonist indicated: for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. Eltrombopag tablets should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon- based therapy. in combination with standard immunosuppressive therapy for the first- line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 13, 2026 | Original application | Approved | None posted |
| Eltrombopag OlamineEQ 12.5MG ACID · tablet;oral | Eltrombopag Olamine | Rx |
| Eltrombopag OlamineEQ 25MG ACID · tablet;oral | Eltrombopag Olamine | Rx |
| Eltrombopag OlamineEQ 75MG ACID · tablet;oral | Eltrombopag Olamine | Rx |
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
