ANDA 75934, held by Mylan Pharms Inc. Nizatidine.
As of Nov 15, 2026, ANDA 75934 (Nizatidine), held by Mylan Pharms Inc, was first approved by FDA on Jul 9, 2002, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 9, 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
