Orange Book product · Generic (ANDA)
NIZATIDINE
NIZATIDINE
At a glance
Jul 09, 2002
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 09, 2002
24 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
NIZATIDINE
Strength
300MG
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
ANDA 075616
Product number
002
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
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
- 2003NIZATIDINEGeneric (ANDA)
ANDA 076383 · APOTEX INC
- 2002NIZATIDINEGeneric (ANDA)
ANDA 075668 · ANI PHARMS
- 2002NIZATIDINEGeneric (ANDA)
ANDA 075934 · MYLAN PHARMS INC
- 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.
