Nateglinide

ANDA 77462, held by Watson Labs. Nateglinide.

As of Nov 15, 2026, ANDA 77462 (Nateglinide), held by Watson Labs, was first approved by FDA on Mar 30, 2011, with 3 approved supplements and 0 published complete response letters.

First approved: Mar 30, 2011
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Mar 30, 2011	Original application	Approved	None posted

Products

2 strengths and forms


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

All 4 submissions, including labeling and manufacturing supplements


Sep 27, 2024	Supplement 3Labeling · Standard review	Approved	None posted
Sep 27, 2024	Supplement 4Labeling · Standard review	Approved	None posted
Jul 30, 2013	Supplement 1Labeling	Approved	None posted
Mar 30, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 77462
Drugs@FDA: Overview at FDA
Company: Watson Laboratories

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