ANDA 90623, held by Aurobindo Pharma. Ranitidine Hydrochloride.
As of Nov 15, 2026, ANDA 90623 (Ranitidine Hydrochloride), held by Aurobindo Pharma, was first approved by FDA on Jul 28, 2010, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 28, 2010 | 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
