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Last Updated: December 12, 2019

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Details for New Drug Application (NDA): 021204

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NDA 021204 describes STARLIX, which is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. Additional details are available on the STARLIX profile page.

The generic ingredient in STARLIX 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 021204
Tradename:STARLIX
Applicant:Novartis
Ingredient:nateglinide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 021204
Mechanism of ActionPotassium Channel Antagonists
Suppliers and Packaging for NDA: 021204
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
STARLIX nateglinide TABLET;ORAL 021204 NDA Novartis Pharmaceuticals Corporation 0078-0351 0078-0351-05 100 TABLET in 1 BOTTLE (0078-0351-05)
STARLIX nateglinide TABLET;ORAL 021204 NDA Novartis Pharmaceuticals Corporation 0078-0352 0078-0352-05 100 TABLET in 1 BOTTLE (0078-0352-05)
Paragraph IV (Patent) Challenges for 021204
Tradename Dosage Ingredient NDA Submissiondate
STARLIX TABLET;ORAL nateglinide 021204 2004-12-22

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength60MG
Approval Date:Dec 22, 2000TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength120MG
Approval Date:Dec 22, 2000TE:RLD:Yes

Expired US Patents for NDA 021204

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis STARLIX nateglinide TABLET;ORAL 021204-002 Dec 22, 2000   Start Trial   Start Trial
Novartis STARLIX nateglinide TABLET;ORAL 021204-001 Dec 22, 2000   Start Trial   Start Trial
Novartis STARLIX nateglinide TABLET;ORAL 021204-002 Dec 22, 2000   Start Trial   Start Trial
Novartis STARLIX nateglinide TABLET;ORAL 021204-002 Dec 22, 2000   Start Trial   Start Trial
Novartis STARLIX nateglinide TABLET;ORAL 021204-002 Dec 22, 2000   Start Trial   Start Trial
Novartis STARLIX nateglinide TABLET;ORAL 021204-001 Dec 22, 2000   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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