ANDA 221019, held by Changzhou Pharm. Eltrombopag Olamine.
As of Nov 15, 2026, ANDA 221019 (Eltrombopag Olamine), held by Changzhou Pharm, was first approved by FDA on Nov 5, 2026, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 5, 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 50MG 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
