Nateglinide

For type 2 diabetes mellitus. ANDA 205544, held by Rising. Nateglinide.

As of Nov 15, 2026, ANDA 205544 (Nateglinide), held by Rising, was first approved by FDA on Jun 18, 2018, with 1 approved supplement and 0 published complete response letters.

First approved: Jun 18, 2018
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
Jun 18, 2018	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


Nov 14, 2024	Supplement 7Labeling · Standard review	Approved	None posted
Jun 18, 2018	Original application	Approved	None posted

Identifiers

Application: ANDA 205544
Drugs@FDA: Overview at FDA
Company: Rising 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