Orange Book product · Brand (NDA)
AXID AR
NIZATIDINE
At a glance
May 09, 1996
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 09, 1996
30 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
NIZATIDINE
Strength
75MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 020555
Product number
001
Marketing status
OTC
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
- 2004AXIDBrand (NDA)
NDA 021494 · BRAINTREE
- 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.
