ANDA 216722, held by Sinopep Allsino. Fulvestrant.
As of Nov 14, 2026, ANDA 216722 (Fulvestrant), held by Sinopep Allsino, was first approved by FDA on Oct 28, 2026, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 28, 2026 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Fulvestrant250MG/5ML (50MG/ML) ยท solution;intramuscular | Fulvestrant | 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
