ANDA 209161, held by Strides Pharma. Ranitidine Hydrochloride.
As of Nov 15, 2026, ANDA 209161 (Ranitidine Hydrochloride), held by Strides Pharma, was first approved by FDA on Feb 22, 2018, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 22, 2018 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ranitidine HydrochlorideEQ 150MG BASE · tablet;oral | Ranitidine Hydrochloride | Discontinued |
| Jul 26, 2024 | Supplement 3Labeling · Standard review | Approved | None posted |
| Jul 26, 2024 | Supplement 2Labeling · Standard review | Approved | None posted |
| Feb 22, 2018 | Original application | Approved | None posted |
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
