ANDA 202647, held by Yung Shin Pharm. Granisetron Hydrochloride.
As of Nov 15, 2026, ANDA 202647 (Granisetron Hydrochloride), held by Yung Shin Pharm, was first approved by FDA on Mar 6, 2020, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 6, 2020 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Granisetron HydrochlorideEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) ยท injectable;injection | Granisetron Hydrochloride | Discontinued |
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
