ANDA 78566, held by Wockhardt USA. Granisetron Hydrochloride.
As of Nov 15, 2026, ANDA 78566 (Granisetron Hydrochloride), held by Wockhardt USA, was first approved by FDA on Feb 29, 2008, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 29, 2008 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Granisetron HydrochlorideEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) · injectable;injection | Granisetron Hydrochloride | Discontinued |
| Feb 25, 2015 | Supplement 2Labeling · Standard review | Approved | None posted |
| Sep 18, 2014 | Supplement 1Labeling · Standard review | Approved | None posted |
| Feb 29, 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
