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Generated: June 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090576

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NDA 090576 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 090576
Tradename:NIZATIDINE
Applicant:Amneal Pharms
Ingredient:nizatidine
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 090576
Medical Subject Heading (MeSH) Categories for 090576
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 Gemini Laboratories, LLC 60846-301 N 60846-301-15
NIZATIDINE nizatidine SOLUTION;ORAL 090576 ANDA Amneal Pharmaceuticals LLC 65162-659 N 65162-659-90

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength15MG/ML
Approval Date:Nov 18, 2009TE:RLD:No

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