Nevirapine

ANDA 203021, held by Apotex Inc. Nevirapine.

As of Nov 15, 2026, ANDA 203021 (Nevirapine), held by Apotex Inc, was first approved by FDA on May 22, 2012, with 2 approved supplements and 0 published complete response letters.

First approved: May 22, 2012
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
May 22, 2012	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Nevirapine200MG · tablet;oral	Nevirapine	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Jan 20, 2015	Supplement 2Labeling · Standard review	Approved	None posted
Mar 12, 2013	Supplement 1Labeling · Standard review	Approved	None posted
May 22, 2012	Original application	Approved	None posted

Identifiers

Application: ANDA 203021
Drugs@FDA: Overview at FDA
Company: Apotex

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