Details for New Drug Application (NDA): 077314

NDA 077314 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 077314

Tradename:	NIZATIDINE
Applicant:	Dr Reddys Labs Ltd
Ingredient:	nizatidine
Patents:	0

Pharmacology for NDA: 077314

Mechanism of Action

Histamine H2 Receptor Antagonists

Medical Subject Heading (MeSH) Categories for 077314

Anti-Ulcer Agents

Histamine H2 Antagonists

Suppliers and Packaging for NDA: 077314

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NIZATIDINE	nizatidine	CAPSULE;ORAL	077314	ANDA	Dr Reddy's Laboratories Limited	55111-310	55111-310-01	100 CAPSULE in 1 BOTTLE (55111-310-01)
NIZATIDINE	nizatidine	CAPSULE;ORAL	077314	ANDA	Dr Reddy's Laboratories Limited	55111-310	55111-310-05	500 CAPSULE in 1 BOTTLE (55111-310-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	150MG
Approval Date:	Sep 15, 2005	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	300MG
Approval Date:	Sep 15, 2005	TE:	AB	RLD:	No

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