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Serving leading biopharmaceutical companies globally:

AstraZeneca
Chinese Patent Office
Dow
Teva
Colorcon
Argus Health
Cipla
Cerilliant
Johnson and Johnson
Harvard Business School

Generated: December 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075616

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NDA 075616 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 eighteen 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. Nineteen suppliers are listed for this compound. Additional details are available on the nizatidine profile page.

Summary for 075616

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 075616

Medical Subject Heading (MeSH) Categories for 075616

Suppliers and Packaging for NDA: 075616

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NIZATIDINE nizatidine CAPSULE;ORAL 075616 ANDA Actavis Pharma, Inc. 0591-3137 0591-3137-60 60 CAPSULE in 1 BOTTLE, PLASTIC (0591-3137-60)
NIZATIDINE nizatidine CAPSULE;ORAL 075616 ANDA Actavis Pharma, Inc. 0591-3138 0591-3138-30 30 CAPSULE in 1 BOTTLE, PLASTIC (0591-3138-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength150MG
Approval Date:Jul 9, 2002TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength300MG
Approval Date:Jul 9, 2002TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Colorcon
Johnson and Johnson
Federal Trade Commission
US Army
Dow
AstraZeneca
Express Scripts
Chinese Patent Office
McKesson
QuintilesIMS

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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