ANDA 77165, held by Dr Reddys. Granisetron Hydrochloride.
As of Nov 15, 2026, ANDA 77165 (Granisetron Hydrochloride Preservative Free), held by Dr Reddys, was first approved by FDA on Dec 31, 2007, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 31, 2007 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Granisetron Hydrochloride Preservative FreeEQ 1MG BASE/ML (EQ 1MG BASE/ML) · injectable;injection | Granisetron Hydrochloride | Discontinued |
| Sep 18, 2014 | Supplement 10Labeling · Standard review | Approved | None posted |
| Dec 31, 2007 | Original application | Approved |
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
