Nevirapine

ANDA 206448, held by Cipla. Nevirapine.

As of Nov 15, 2026, ANDA 206448 (Nevirapine), held by Cipla, was first approved by FDA on Oct 15, 2015, with 5 approved supplements and 0 published complete response letters.

First approved: Oct 15, 2015
Review: Standard
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Oct 15, 2015	Original application	Approved	Label Letter

Products

1 strengths and forms

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

All 6 submissions, including labeling and manufacturing supplements


Jul 1, 2025	Supplement 7Labeling · Standard review	Approved	None posted
Nov 29, 2023	Supplement 6Labeling · Standard review	Approved	None posted
Aug 14, 2019	Supplement 1Labeling · Standard review	Approved	None posted
Aug 14, 2019	Supplement 3Labeling · Standard review	Approved	None posted
Aug 14, 2019	Supplement 5Labeling · Standard review	Approved	None posted
Oct 15, 2015	Original application	Approved	Label Letter

Identifiers

Application: ANDA 206448
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