Nevirapine

ANDA 204621, held by Alvogen. Nevirapine.

As of Nov 15, 2026, ANDA 204621 (Nevirapine), held by Alvogen, was first approved by FDA on Sep 11, 2015, with 3 approved supplements and 0 published complete response letters.

First approved: Sep 11, 2015
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

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


Sep 11, 2015	Original application	Approved	None posted
Jul 10, 2015	Original application	Approved	Letter

Products

2 strengths and forms


Nevirapine400MG · tablet, extended release;oral	Nevirapine	Discontinued
Nevirapine100MG · tablet, extended release;oral	Nevirapine	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Dec 13, 2022	Supplement 6Labeling · Standard review	Approved	None posted
Aug 14, 2019	Supplement 4Labeling · Standard review	Approved	None posted
Aug 14, 2019	Supplement 5Labeling · Standard review	Approved	None posted
Sep 11, 2015	Original application	Approved	None posted
Jul 10, 2015	Original application	Approved	Letter

Identifiers

Application: ANDA 204621
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