ANDA 75806, held by Pharmobedient. Nizatidine.
As of Nov 15, 2026, ANDA 75806 (Nizatidine), held by Pharmobedient, was first approved by FDA on Jul 5, 2002, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 5, 2002 | Original application | Approved |
| Nizatidine150MG · capsule;oral | Nizatidine | Discontinued |
| Nizatidine300MG · capsule;oral | Nizatidine | 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
