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Last Updated: January 1, 2026

Details for New Drug Application (NDA): 090576

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NDA 090576 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 090576

Tradename:	NIZATIDINE
Applicant:	Amneal Pharms
Ingredient:	nizatidine
Patents:	0

Pharmacology for NDA: 090576

Mechanism of Action	Histamine H2 Receptor Antagonists

Medical Subject Heading (MeSH) Categories for 090576

Anti-Ulcer Agents
Histamine H2 Antagonists

Suppliers and Packaging for NDA: 090576

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NIZATIDINE	nizatidine	SOLUTION;ORAL	090576	ANDA	Amneal Pharmaceuticals LLC	60846-301	60846-301-15	480 mL in 1 BOTTLE (60846-301-15)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;ORAL			Strength	15MG/ML
Approval Date:	Nov 18, 2009	TE:		RLD:	No

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