Nizatidine

Overview

A histamine H2 receptor antagonist with low toxicity that inhibits gastric acid secretion. The drug is used for the treatment of duodenal ulcers.

Indication

For the treatment of acid-reflux disorders (GERD), peptic ulcer disease, active benign gastric ulcer, and active duodenal ulcer.

Associated Conditions

Duodenal Ulcer
Esophagitis
Gastric Ulcer
Gastro-esophageal Reflux Disease (GERD)
Helicobacter Pylori Infection
Peptic Ulcer Disease
Stress Ulcers

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Clinical Trial to Compare Rebamipide/Nizatidine Combination Therapy With Nizatidine Monotherapy in Patients With Gastritis	2021/10/11	NCT05072938	Phase 4	Completed	Daewoong Pharmaceutical Co. LTD.
Proton Pump Inhibitors and Risk of Community-acquired Pneumonia	2015/09/22	NCT02555852	N/A	Completed	Canadian Network for Observational Drug Effect Studies, CNODES
Modulation of Heme Oxygenase 1 by Nizatidine and Lisinopril in Healthy Subjects	2014/09/05	NCT02232308	Phase 1	Completed	Adil Bharucha
Bioequivalence Study of Nizatidine Capsules 300 mg of Dr.Reddy's Laboratories Limited Under Non- Fasting Conditions	2010/07/14	NCT01161927	Phase 1	Completed	Dr. Reddy's Laboratories Limited
Bioequivalence Study of Nizatidine Capsules 300 mg of Dr.Reddy's Laboratories Limited Under Fasting Conditions	2010/07/14	NCT01161940	Phase 1	Completed	Dr. Reddy's Laboratories Limited
Weight Gain Management in Patients With Schizophrenia	2007/06/13	NCT00486005	Phase 4	Completed	Eli Lilly and Company
Safety and Efficacy Study of Axid Use in Infants Suffering From Gastroesophageal Reflux Disease (GERD)	2006/09/08	NCT00373334	Phase 3	Completed	Braintree Laboratories

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Nizatidine	Carilion Materials Management	68151-0017	ORAL	150 mg in 1 1	10/13/2016
Nizatidine	Rebel Distributors Corp	21695-043	ORAL	300 mg in 1 1	9/12/2011
Nizatidine	nizatidine	16590-741	ORAL	150 mg in 1 1	1/14/2010
Nizatidine	Dr Reddy's Laboratories Limited	55111-311	ORAL	300 mg in 1 1	12/6/2018
Nizatidine	NuCare Pharmaceuticals,Inc.	68071-1633	ORAL	150 mg in 1 1	2/11/2021
Nizatidine	Rebel Distributors Corp	42254-093	ORAL	150 mg in 1 1	9/12/2011
Nizatidine	NuCare Pharmaceuticals,Inc.	68071-5043	ORAL	150 mg in 1 1	2/19/2021
Nizatidine	Medsource Pharmaceuticals	45865-374	ORAL	150 mg in 1 1	8/15/2015
nizatidine	Rebel Distributors Corp	21695-375	ORAL	150 mg in 1 1	8/24/2010
Nizatidine	Dr Reddy's Laboratories Limited	55111-310	ORAL	150 mg in 1 1	12/6/2018

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
NIZATIDINE-RJIC nizatidine 300mg capsule blister pack	425516	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	1/30/2024
NIZATIDINE-RJIC nizatidine 150mg capsule blister pack	425515	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	1/30/2024
NIZATIDINE-DWRN nizatidine 300mg capsule blister pack	425514	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	1/30/2024
TACIDINE RELIEF nizatidine 150mg capsule blister pack	98741	Alphapharm Pty Ltd	Medicine	A	12/12/2003
TACIDINE nizatidine 150mg capsule blister pack	94204	Alphapharm Pty Ltd	Medicine	A	4/29/2003
NIZAC nizatidine 300mg capsule blister pack	96963	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	9/18/2003
TAZAC PULVULES nizatidine 150mg capsule	284130	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	5/11/2017
NIZATIDINE-DWRN nizatidine 150mg capsule blister pack	425513	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	1/30/2024
TACIDINE nizatidine 300mg capsule blister pack	94205	Alphapharm Pty Ltd	Medicine	A	4/29/2003
NIZAC nizatidine 150mg capsule blister pack	284129	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	5/11/2017

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
NU-NIZATIDINE	nu-pharm inc	02247052	Capsule - Oral	300 MG	N/A
AXID	pendopharm division of pharmascience inc	00778346	Capsule - Oral	300 MG	12/31/1988
NIZATIDINE-150	PRO DOC LIMITEE	02239558	Capsule - Oral	150 MG / CAP	2/12/2001
GEN-NIZATIDINE	genpharm ulc	02246046	Capsule - Oral	150 MG	7/12/2002
GEN-NIZATIDINE	genpharm ulc	02246047	Capsule - Oral	300 MG	7/12/2002
PMS-NIZATIDINE	Pharmascience Inc	02520338	Capsule - Oral	150 MG	N/A
DOM-NIZATIDINE 150MG CAPSULES	dominion pharmacal	02185814	Capsule - Oral	150 MG	10/31/2001
PMS-NIZATIDINE	Pharmascience Inc	02177722	Capsule - Oral	300 MG	4/28/1998
PHL-NIZATIDINE	pharmel inc	02238194	Capsule - Oral	150 MG	3/1/1999
PHL-NIZATIDINE	pharmel inc	02238195	Capsule - Oral	300 MG	3/1/1999

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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