Orange Book product · Generic (ANDA)
NIZATIDINE
NIZATIDINE
At a glance
Jan 23, 2003
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 23, 2003
23 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
NIZATIDINE
Strength
150MG
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
ANDA 076383
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of NIZATIDINE
- 2004AXIDBrand (NDA)
NDA 021494 · BRAINTREE
- 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
- 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.
