ANDA 203454, held by Pharmobedient. Granisetron Hydrochloride.
As of Nov 15, 2026, ANDA 203454 (Granisetron Hydrochloride), held by Pharmobedient, was first approved by FDA on Apr 4, 2017, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 4, 2017 | Original application | Approved | None posted |
| Granisetron HydrochlorideEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) · injectable;injection | Granisetron Hydrochloride | Discontinued |
| Granisetron HydrochlorideEQ 1MG BASE/ML (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
