ANDA 79076, held by Mylan Labs Ltd. Ranitidine Hydrochloride.
As of Nov 15, 2026, ANDA 79076 (Ranitidine Hydrochloride), held by Mylan Labs Ltd, was first approved by FDA on Jun 9, 2016, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 9, 2016 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ranitidine HydrochlorideEQ 25MG BASE/ML ยท injectable;injection | 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
