ANDA 77458, held by Hikma. Ranitidine Hydrochloride.
As of Nov 15, 2026, ANDA 77458 (Ranitidine Hydrochloride), held by Hikma, was first approved by FDA on Feb 16, 2006, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 16, 2006 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ranitidine HydrochlorideEQ 25MG BASE/ML ยท injectable;injection | Ranitidine Hydrochloride | Discontinued |
| Jan 29, 2010 | Supplement 2Labeling | Approved | None posted |
| Jun 18, 2009 | Supplement 1Labeling | Approved | None posted |
| Feb 16, 2006 | Original application | Approved |
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
