FDA Orange Book · active-ingredient family
Nizatidine
Nizatidine is approved as 3 brand and 10 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:AXID · NDA 021494
3
Brand (NDA)
10
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, solution, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| AXIDRLD | BRAINTREE | NDA 021494 | — | May 25, 2004 | |
| AXID ARRLD | HALEON US HOLDINGS | NDA 020555 | — | May 09, 1996 | |
| AXID×2 | SMITHKLINE BEECHAM | NDA 019508 | — | Apr 12, 1988 |
Generic (ANDA) products (10)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NIZATIDINE×2 | GLENMARK PHARMS | ANDA 090618 | — | Jul 15, 2011 | |
| NIZATIDINE | AMNEAL PHARMS | ANDA 090576 | — | Nov 18, 2009 | |
| NIZATIDINE×2 | DR REDDYS LABS LTD | ANDA 077314 | AB | Sep 15, 2005 | |
| NIZATIDINE×2 | APOTEX INC | ANDA 076383 | — | Jan 23, 2003 | |
| NIZATIDINE×2 | ANI PHARMS | ANDA 075668 | — | Sep 12, 2002 | |
| NIZATIDINE×2 | MYLAN PHARMS INC | ANDA 075934 | — | Jul 09, 2002 | |
| NIZATIDINE×2 | WATSON LABS | ANDA 075616 | AB | Jul 09, 2002 | |
| NIZATIDINE×2 | ANI PHARMS | ANDA 075461 | — | Jul 08, 2002 | |
| NIZATIDINE×2 | EPIC PHARMA LLC | ANDA 076178 | AB | Jul 05, 2002 | |
| NIZATIDINE×2 | PHARMOBEDIENT | ANDA 075806 | — | Jul 05, 2002 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Nizatidine — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
