Nateglinide

For type 2 diabetes mellitus. ANDA 77463, held by Strides Pharma Intl. Nateglinide.

As of Nov 15, 2026, ANDA 77463 (Nateglinide), held by Strides Pharma Intl, was first approved by FDA on Sep 9, 2009, with 5 approved supplements and 0 published complete response letters.

First approved: Sep 9, 2009
Supplements approved: 5
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Nateglinide is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use: Nateglinide should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Sep 9, 2009	Original application	Approved	Label Letter Letter

Products

2 strengths and forms


Nateglinide60MG · tablet;oral	Nateglinide	Rx
Nateglinide120MG · tablet;oral	Nateglinide	Rx

All 6 submissions, including labeling and manufacturing supplements


Oct 13, 2022	Supplement 9Labeling · Standard review	Approved	None posted
Oct 13, 2022	Supplement 10Labeling · Standard review	Approved	None posted
Oct 13, 2022	Supplement 12Labeling · Standard review	Approved	None posted
Jul 30, 2013	Supplement 1Labeling	Approved	None posted
Jul 30, 2013	Supplement 5Labeling	Approved	None posted
Sep 9, 2009	Original application	Approved	Label Letter Letter

Identifiers

Application: ANDA 77463
Drugs@FDA: Overview at FDA
Company: Strides Pharma International

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