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Generated: December 14, 2017

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

Tradename:1
Applicant:1
Ingredient:1
Patents:0
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 68382-721-05 500 TABLET, FILM COATED in 1 BOTTLE (68382-721-05)
NATEGLINIDE nateglinide TABLET;ORAL 205248 ANDA Zydus Pharmaceuticals (USA) Inc. 68382-721 68382-721-77 10 BLISTER PACK in 1 CARTON (68382-721-77) > 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-721-30)

Summary for product number 001

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

Summary for product number 002

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


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Serving leading biopharmaceutical companies globally:

Express Scripts
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McKinsey
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Novartis

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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