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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
US Army
US Department of Justice

Generated: March 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205248

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NDA 205248 describes NATEGLINIDE, which is a drug marketed by Alvogen Malta, Dr Reddys Labs Ltd, Par Pharm, Teva Pharms, Watson Labs, and Zydus Pharms Usa Inc, and is included in six NDAs. It is available from eleven suppliers. Additional details are available on the NATEGLINIDE profile page.

The generic ingredient in NATEGLINIDE is nateglinide. There are nine drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the nateglinide profile page.
Summary for 205248
Applicant:Zydus Pharms Usa Inc
Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details
Pharmacology for NDA: 205248
Mechanism of ActionPotassium Channel Antagonists
Suppliers and Packaging for NDA: 205248
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NATEGLINIDE nateglinide TABLET;ORAL 205248 ANDA Zydus Pharmaceuticals (USA) Inc. 68382-721 N 68382-721-10
NATEGLINIDE nateglinide TABLET;ORAL 205248 ANDA Zydus Pharmaceuticals (USA) Inc. 68382-721 N 68382-721-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength60MG
Approval Date:Jul 6, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength120MG
Approval Date:Jul 6, 2016TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Chinese Patent Office
US Army
Daiichi Sankyo

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