ANDA 78312, held by Amneal Pharms. Ranitidine Hydrochloride.
As of Nov 15, 2026, ANDA 78312 (Ranitidine Hydrochloride), held by Amneal Pharms, was first approved by FDA on Sep 2, 2008, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 2, 2008 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ranitidine HydrochlorideEQ 15MG BASE/ML ยท syrup;oral | Ranitidine Hydrochloride | Discontinued |
| Apr 30, 2010 | Supplement 2Labeling | Approved | None posted |
| Sep 2, 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
