Sold as Axid, Axid Ar. Every FDA application for this active ingredient: 3 branded and 10 generic.
As of Nov 15, 2026, FDA lists 13 applications for Nizatidine (sold as Axid, Axid Ar), first approved Apr 12, 1988, with 4 new uses approved and 0 published complete response letters.
| Product | Part | Spending, 2025 | Change | Beneficiaries |
|---|---|---|---|---|
| Nizatidine | Part D | $539K | +29% | 1,457 |
| Apr 12, 1988 | AxidNDA 19508 · New molecular entity | Smithkline Beecham | 27 | Discontinued |
| May 9, 1996 | Axid ArNDA 20555 · New dosage form | Haleon US Holdings | 6 | Marketed |
| Jul 5, 2002 | NizatidineANDA 75806 | Pharmobedient | 0 | Discontinued |
| Jul 5, 2002 | NizatidineANDA 76178 | Epic Pharma LLC | 2 | Marketed |
| Jul 8, 2002 | NizatidineANDA 75461 | Ani Pharms | 1 | Discontinued |
| Jul 9, 2002 | NizatidineANDA 75616 | Watson Labs | 0 | Marketed |
| Jul 9, 2002 | NizatidineANDA 75934 | Mylan Pharms Inc | 0 | Discontinued |
| Sep 12, 2002 | NizatidineANDA 75668 | Ani Pharms | 2 | Discontinued |
| Jan 23, 2003 | NizatidineANDA 76383 | Apotex Inc | 0 | Discontinued |
| May 25, 2004 | AxidNDA 21494 · New dosage form | Braintree | 1 | Discontinued |
| Sep 15, 2005 | NizatidineANDA 77314 | Dr Reddys Labs Ltd | 0 | Marketed |
| Nov 18, 2009 | NizatidineANDA 90576 | Amneal Pharms | 0 | Discontinued |
| Jul 15, 2011 | NizatidineANDA 90618 | Glenmark Pharms | 0 | Discontinued |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
Mylan Pharms Inc