ANDA 202648, held by Yung Shin Pharm. Granisetron Hydrochloride.
As of Nov 15, 2026, ANDA 202648 (Granisetron Hydrochloride), held by Yung Shin Pharm, was first approved by FDA on Jun 29, 2020, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 29, 2020 | Original application | Approved | None posted |
| Granisetron HydrochlorideEQ 1MG BASE/ML (EQ 1MG BASE/ML) · injectable;injection | Granisetron Hydrochloride | Discontinued |
| Granisetron HydrochlorideEQ 4MG BASE/4ML (EQ 1MG BASE/ML) · 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
