Nateglinide

ANDA 205055, held by Alvogen. Nateglinide.

As of Nov 15, 2026, ANDA 205055 (Nateglinide), held by Alvogen, was first approved by FDA on Dec 11, 2015, with 2 approved supplements and 0 published complete response letters.

First approved: Dec 11, 2015
Review: Standard
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Dec 11, 2015	Original application	Approved	Letter

Products

2 strengths and forms


Nateglinide60MG · tablet;oral	Nateglinide	Discontinued
Nateglinide120MG · tablet;oral	Nateglinide	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Mar 15, 2023	Supplement 2Labeling · Standard review	Approved	None posted
Dec 3, 2018	Supplement 1Labeling · Standard review	Approved	None posted
Dec 11, 2015	Original application	Approved	Letter

Identifiers

Application: ANDA 205055
Drugs@FDA: Overview at FDA
Company: Alvogen

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