Prevents nausea and/or vomiting associated with initial and repeat courses of emetogenic…. ANDA 78096, held by Fresenius Kabi USA. Granisetron Hydrochloride.
As of Nov 15, 2026, ANDA 78096 (Granisetron Hydrochloride Preservative Free), held by Fresenius Kabi USA, was first approved by FDA on Jun 30, 2008, with 3 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. 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 |
|---|---|---|---|
| Jun 30, 2008 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Granisetron Hydrochloride Preservative FreeEQ 1MG BASE/ML (EQ 1MG BASE/ML) · injectable;injection | Granisetron Hydrochloride | Rx |
| May 19, 2022 | Supplement 6Labeling · Standard review | Approved | None posted |
| Sep 18, 2014 | Supplement 5Labeling · Standard review | Approved | |
| Feb 14, 2013 | Supplement 2Labeling · Standard review | Approved | None posted |
| Jun 30, 2008 | 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
