Prevents nausea and/or vomiting associated with initial and repeat courses of emetogenic…. ANDA 78629, held by Hikma Farmaceutica. Granisetron Hydrochloride.
As of Nov 15, 2026, ANDA 78629 (Granisetron Hydrochloride), held by Hikma Farmaceutica, was first approved by FDA on Dec 23, 2009, with 2 approved supplements and 0 published complete response letters.
Granisetron Hydrochloride Injection, USP 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. Granisetron Hydrochloride Injection, USP is a serotonin-3 (5-HT 3 ) receptor antagonist indicated for: Prevention of nausea and/or vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 23, 2009 | Original application | Approved | None posted |
| Granisetron HydrochlorideEQ 1MG BASE/ML (EQ 1MG BASE/ML) · injectable;injection | Granisetron Hydrochloride | Rx |
| Granisetron HydrochlorideEQ 4MG BASE/4ML (EQ 1MG BASE/ML) · injectable;injection | Granisetron Hydrochloride | Rx |
| Sep 18, 2014 | Supplement 7Labeling · Standard review | Approved | None posted |
| Sep 14, 2014 | Supplement 6Labeling · Standard review | Approved | None posted |
| Dec 23, 2009 | 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
