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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 075461

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NDA 075461 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, Norvium Bioscience, 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 075461

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

Medical Subject Heading (MeSH) Categories for 075461

Anti-Ulcer Agents
Histamine H2 Antagonists

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	150MG
Approval Date:	Jul 8, 2002	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	300MG
Approval Date:	Jul 8, 2002	TE:		RLD:	No

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