ANDA 211058, held by Aurobindo Pharma. Ranitidine Hydrochloride.
As of Nov 15, 2026, ANDA 211058 (Ranitidine Hydrochloride), held by Aurobindo Pharma, was first approved by FDA on Jul 16, 2018, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 16, 2018 | Original application | Approved | None posted |
| Ranitidine HydrochlorideEQ 150MG BASE · capsule;oral | Ranitidine Hydrochloride | Discontinued |
| Ranitidine HydrochlorideEQ 300MG BASE · capsule;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
