ANDA 91274, held by Am Regent. Granisetron Hydrochloride.
As of Nov 15, 2026, ANDA 91274 (Granisetron Hydrochloride), held by Am Regent, was first approved by FDA on Sep 22, 2010, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 22, 2010 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Granisetron HydrochlorideEQ 1MG BASE/ML (EQ 1MG BASE/ML) · injectable;injection | Granisetron Hydrochloride | Discontinued |
| Sep 18, 2014 | Supplement 2Labeling · Standard review | Approved | None posted |
| Sep 22, 2010 | Original application | Approved | None posted |
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
