ANDA 75212, held by Ani Pharms. Ranitidine Hydrochloride.
As of Nov 15, 2026, ANDA 75212 (Ranitidine Hydrochloride), held by Ani Pharms, was first approved by FDA on Jan 14, 2000, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 14, 2000 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ranitidine HydrochlorideEQ 75MG BASE ยท tablet;oral | Ranitidine Hydrochloride | Discontinued |
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
