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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 075616

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NDA 075616 describes NIZATIDINE, which is a drug marketed by Ani Pharms, Apotex Inc, Dr Reddys Labs Ltd, Epic Pharma Llc, Glenmark Pharms Inc, Mylan Pharms Inc, Pharmobedient, Watson Labs, and Amneal Pharms, and is included in ten NDAs. It is available from four suppliers. Additional details are available on the NIZATIDINE profile page.

The generic ingredient in NIZATIDINE is nizatidine. There are seven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the nizatidine profile page.

Summary for 075616

Tradename:	NIZATIDINE
Applicant:	Watson Labs
Ingredient:	nizatidine
Patents:	0

Pharmacology for NDA: 075616

Mechanism of Action	Histamine H2 Receptor Antagonists

Medical Subject Heading (MeSH) Categories for 075616

Anti-Ulcer Agents
Histamine H2 Antagonists

Suppliers and Packaging for NDA: 075616

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NIZATIDINE	nizatidine	CAPSULE;ORAL	075616	ANDA	Actavis Pharma, Inc.	0591-3137	0591-3137-60	60 CAPSULE in 1 BOTTLE, PLASTIC (0591-3137-60)
NIZATIDINE	nizatidine	CAPSULE;ORAL	075616	ANDA	Actavis Pharma, Inc.	0591-3138	0591-3138-30	30 CAPSULE in 1 BOTTLE, PLASTIC (0591-3138-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	150MG
Approval Date:	Jul 9, 2002	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	300MG
Approval Date:	Jul 9, 2002	TE:	AB	RLD:	No

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