Starlix

NDA 21204, held by Novartis. Nateglinide.

As of Nov 15, 2026, NDA 21204 (Starlix), held by Novartis, was first approved by FDA on Dec 22, 2000, with 16 approved supplements and 0 published complete response letters.

First approved: Dec 22, 2000
Review: Standard
Supplements approved: 16
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below


Oct 20, 2003	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Dec 22, 2000	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Products

2 strengths and forms


Starlix60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Nateglinide	DiscontinuedReference drug
Starlix120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Nateglinide	DiscontinuedReference drug

All 17 submissions, including labeling and manufacturing supplements


Oct 28, 2021	Supplement 25Labeling · Standard review	Approved	Letter Label
May 10, 2018	Supplement 23Labeling · Standard review	Approved	Label Letter
Mar 14, 2017	Supplement 15Labeling · Standard review	Approved	Label Letter
Nov 30, 2016	Supplement 20Manufacturing · Standard review	Approved	None posted
Apr 7, 2016	Supplement 19Manufacturing · Standard review	Approved	None posted
Dec 2, 2015	Supplement 18Manufacturing · Standard review	Approved	None posted
Aug 24, 2011	Supplement 14Labeling · Standard review	Approved	Letter Label
Jul 15, 2008	Supplement 11Labeling · Standard review	Approved	Letter Label
Nov 9, 2006	Supplement 10Labeling · Standard review	Approved	Letter Label
Jul 1, 2004	Supplement 9Labeling · Standard review	Approved	Label Letter
Oct 20, 2003	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Nov 26, 2002	Supplement 5Labeling · Standard review	Approved	Letter Label
Sep 25, 2002	Supplement 4Manufacturing · Standard review	Approved	None posted
Feb 27, 2002	Supplement 3Manufacturing · Standard review	Approved	None posted
Jan 3, 2002	Supplement 2Manufacturing · Standard review	Approved	None posted
May 1, 2001	Supplement 1Manufacturing · Standard review	Approved	None posted
Dec 22, 2000	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21204
Drugs@FDA: Overview at FDA
Company: Novartis Pharmaceuticals Corporation

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters