ANDA 209160, held by Strides Pharma. Ranitidine Hydrochloride.
As of Nov 15, 2026, ANDA 209160 (Ranitidine Hydrochloride), held by Strides Pharma, was first approved by FDA on Mar 5, 2018, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 5, 2018 | 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
