Nateglinide

For type 2 diabetes mellitus. ANDA 206432, held by Cadila Pharms Ltd. Nateglinide.

As of Nov 15, 2026, ANDA 206432 (Nateglinide), held by Cadila Pharms Ltd, was first approved by FDA on Apr 19, 2019, with 1 approved supplement and 0 published complete response letters.

First approved: Apr 19, 2019
Review: Standard
Supplements approved: 1
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Nateglinide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use: Nateglinide tablets 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 2 submissions below

Date	Submission	Status	Documents
Apr 19, 2019	Original application	Approved	None posted

Products

2 strengths and forms


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

All 2 submissions, including labeling and manufacturing supplements


Jan 19, 2023	Supplement 4Labeling · Standard review	Approved	None posted
Apr 19, 2019	Original application	Approved	None posted

Identifiers

Application: ANDA 206432
Drugs@FDA: Overview at FDA
Company: Cadila Pharmaceuticals

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