ANDA 219282, held by Pharmobedient. Granisetron Hydrochloride.
As of Nov 15, 2026, ANDA 219282 (Granisetron Hydrochloride), held by Pharmobedient, was first approved by FDA on Mar 17, 2025, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Granisetron is indicated for the prevention of: Nausea and vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin. Nausea and vomiting associated with radiation, including total body irradiation and fractionated abdominal radiation.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 17, 2025 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Granisetron HydrochlorideEQ 2MG BASE/10ML · solution;oral | Granisetron Hydrochloride | 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
