Nevirapine

ANDA 77956, held by Cipla. Nevirapine.

As of Nov 15, 2026, ANDA 77956 (Nevirapine), held by Cipla, was first approved by FDA on May 22, 2012, with 6 approved supplements and 0 published complete response letters.

First approved: May 22, 2012
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
May 22, 2012	Original application	Approved	Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Nevirapine200MG · tablet;oral	Nevirapine	Rx

All 7 submissions, including labeling and manufacturing supplements


Dec 6, 2019	Supplement 22Labeling · Standard review	Approved	None posted
Dec 6, 2019	Supplement 23Labeling · Standard review	Approved	None posted
Dec 6, 2019	Supplement 24Labeling · Standard review	Approved	None posted
Jan 20, 2015	Supplement 16Labeling · Standard review	Approved	None posted
Jan 20, 2015	Supplement 20Labeling · Standard review	Approved	None posted
Jul 24, 2013	Supplement 18Labeling · Standard review	Approved	None posted
May 22, 2012	Original application	Approved	Letter

Identifiers

Application: ANDA 77956
Drugs@FDA: Overview at FDA
Company: Cipla

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