Nevirapine

ANDA 203411, held by Sandoz. Nevirapine.

As of Nov 15, 2026, ANDA 203411 (Nevirapine), held by Sandoz, was first approved by FDA on Apr 3, 2014, with 4 approved supplements and 0 published complete response letters.

First approved: Apr 3, 2014
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Apr 3, 2014	Original application	Approved	Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Nevirapine400MG · tablet, extended release;oral	Nevirapine	Rx

All 5 submissions, including labeling and manufacturing supplements


Feb 27, 2025	Supplement 9Labeling · Standard review	Approved	None posted
Nov 25, 2022	Supplement 8Labeling · Standard review	Approved	None posted
Aug 29, 2019	Supplement 4Labeling · Standard review	Approved	None posted
Aug 29, 2019	Supplement 5Labeling · Standard review	Approved	None posted
Apr 3, 2014	Original application	Approved	Letter

Identifiers

Application: ANDA 203411
Drugs@FDA: Overview at FDA
Company: Sandoz

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