Nevirapine

ANDA 78644, held by Prinston Inc. Nevirapine.

As of Nov 15, 2026, ANDA 78644 (Nevirapine), held by Prinston Inc, was first approved by FDA on May 22, 2012, with 4 approved supplements and 0 published complete response letters.

First approved: May 22, 2012
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
May 22, 2012	Original application	Approved	Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Nevirapine200MG · tablet;oral	Nevirapine	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Jan 8, 2024	Supplement 6Labeling · Standard review	Approved	None posted
Jun 29, 2020	Supplement 5Labeling · Standard review	Approved	None posted
Jun 29, 2020	Supplement 3Labeling · Standard review	Approved	None posted
Jan 20, 2015	Supplement 2Labeling · Standard review	Approved	None posted
May 22, 2012	Original application	Approved	Letter

Identifiers

Application: ANDA 78644
Drugs@FDA: Overview at FDA
Company: Prinston Pharmaceutical

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