Orange Book product · Brand (NDA)
AXID
NIZATIDINE
At a glance
May 25, 2004
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 25, 2004
22 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
NIZATIDINE
Strength
15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
SOLUTION
Route
ORAL
TE code
Not listed
Application
NDA 021494
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 1996AXID ARBrand (NDA)
NDA 020555 · HALEON US HOLDINGS
- 1988AXIDBrand (NDA)
NDA 019508 · SMITHKLINE BEECHAM
- 2011NIZATIDINEGeneric (ANDA)
ANDA 090618 · GLENMARK PHARMS
- 2009NIZATIDINEGeneric (ANDA)
ANDA 090576 · AMNEAL PHARMS
- 2005NIZATIDINEGeneric (ANDA)
ANDA 077314 · DR REDDYS LABS LTD
- 2003NIZATIDINEGeneric (ANDA)
ANDA 076383 · APOTEX INC
- 2002NIZATIDINEGeneric (ANDA)
ANDA 075668 · ANI PHARMS
- 2002NIZATIDINEGeneric (ANDA)
ANDA 075934 · MYLAN PHARMS INC
- 2002NIZATIDINEGeneric (ANDA)
ANDA 075616 · WATSON LABS
- 2002NIZATIDINEGeneric (ANDA)
ANDA 075461 · ANI PHARMS
- 2002NIZATIDINEGeneric (ANDA)
ANDA 076178 · EPIC PHARMA LLC
- 2002NIZATIDINEGeneric (ANDA)
ANDA 075806 · PHARMOBEDIENT
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.
