Nevirapine

ANDA 207698, held by Aurobindo Pharma. Nevirapine.

As of Nov 15, 2026, ANDA 207698 (Nevirapine), held by Aurobindo Pharma, was first approved by FDA on Feb 28, 2017, with 3 approved supplements and 0 published complete response letters.

First approved: Feb 28, 2017
Review: Standard
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
Feb 28, 2017	Original application	Approved	None posted

Products

1 strengths and forms

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

All 4 submissions, including labeling and manufacturing supplements


Nov 2, 2022	Supplement 6Labeling · Standard review	Approved	None posted
Aug 21, 2019	Supplement 2Labeling · Standard review	Approved	None posted
Aug 21, 2019	Supplement 4Labeling · Standard review	Approved	None posted
Feb 28, 2017	Original application	Approved	None posted

Identifiers

Application: ANDA 207698
Drugs@FDA: Overview at FDA
Company: Aurobindo Pharma

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