ANDA 78890, held by Lannett Co Inc. Ranitidine Hydrochloride.
As of Nov 15, 2026, ANDA 78890 (Ranitidine Hydrochloride), held by Lannett Co Inc, was first approved by FDA on Jul 1, 2010, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 1, 2010 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ranitidine HydrochlorideEQ 15MG BASE/ML ยท syrup;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
