ANDA 91091, held by Nostrum Labs Inc. Ranitidine Hydrochloride.
As of Nov 15, 2026, ANDA 91091 (Ranitidine Hydrochloride), held by Nostrum Labs Inc, was first approved by FDA on Sep 20, 2011, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 20, 2011 | 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
