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Generated: June 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077314

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NDA 077314 describes NIZATIDINE, which is a drug marketed by Ani Pharms Inc, Apotex Inc, Dr Reddys Labs Ltd, Glenmark Generics, Mylan Pharms Inc, Sandoz, Watson Labs, and Amneal Pharms, and is included in ten NDAs. It is available from sixteen 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. Sixteen 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
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 077314
Medical Subject Heading (MeSH) Categories for 077314
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 N 55111-310-01
NIZATIDINE nizatidine CAPSULE;ORAL 077314 ANDA Dr Reddy's Laboratories Limited 55111-310 N 55111-310-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength150MG
Approval Date:Sep 15, 2005TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength300MG
Approval Date:Sep 15, 2005TE:ABRLD:No

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