ANDA 76124, held by Actavis Mid Atlantic. Ranitidine Hydrochloride.
As of Nov 15, 2026, ANDA 76124 (Ranitidine Hydrochloride), held by Actavis Mid Atlantic, was first approved by FDA on Feb 21, 2007, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 21, 2007 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ranitidine HydrochlorideEQ 15MG BASE/ML ยท syrup;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
