ANDA 75519, held by Sandoz. Ranitidine Hydrochloride.
As of Nov 15, 2026, ANDA 75519 (Ranitidine Hydrochloride), held by Sandoz, was first approved by FDA on Sep 26, 2002, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 26, 2002 | Original application | Approved | None posted |
| 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
