Prevents nausea and/or vomiting associated with initial and repeat courses of emetogenic…. ANDA 204238, held by Eugia Pharma. Granisetron Hydrochloride.
As of Nov 15, 2026, ANDA 204238 (Granisetron Hydrochloride), held by Eugia Pharma, was first approved by FDA on Jul 6, 2016, with 1 approved supplement and 0 published complete response letters.
Granisetron hydrochloride injection, is a serotonin-3 (5-HT 3 ) receptor antagonist indicated for: The prevention of nausea and/or vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin. The prevention and treatment of postoperative nausea and vomiting in adults. As with other antiemetics, routine prophylaxis is not recommended in patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 6, 2016 | 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 |
| Mar 24, 2025 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jul 6, 2016 | 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
