ANDA 207578, held by Aurobindo Pharma. Ranitidine Hydrochloride.
As of Nov 15, 2026, ANDA 207578 (Ranitidine Hydrochloride), held by Aurobindo Pharma, was first approved by FDA on Nov 13, 2017, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 13, 2017 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ranitidine HydrochlorideEQ 150MG 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
