ANDA 77476, held by Sun Pharma Canada. Ranitidine Hydrochloride.
As of Nov 15, 2026, ANDA 77476 (Ranitidine Hydrochloride), held by Sun Pharma Canada, was first approved by FDA on Jun 13, 2011, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 13, 2011 | Original application | Approved | None posted |
| 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
