Nevirapine

ANDA 207684, held by Cipla. Nevirapine.

As of Nov 15, 2026, ANDA 207684 (Nevirapine), held by Cipla, was first approved by FDA on Aug 3, 2017, with 1 approved supplement and 0 published complete response letters.

First approved: Aug 3, 2017
Review: Standard
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Aug 3, 2017	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Nevirapine50MG/5ML · suspension;oral	Nevirapine	Rx

All 2 submissions, including labeling and manufacturing supplements


Dec 21, 2018	Supplement 1Labeling · Standard review	Approved	None posted
Aug 3, 2017	Original application	Approved	None posted

Identifiers

Application: ANDA 207684
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