Ribavirin

ANDA 76192, held by Chartwell Rx. Ribavirin.

As of Nov 14, 2026, ANDA 76192 (Ribavirin), held by Chartwell Rx, was first approved by FDA on Apr 6, 2004, with 9 approved supplements and 0 published complete response letters.

First approved: Apr 6, 2004
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Apr 6, 2004	Original application	Approved	Label Exclusivity Letter Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Ribavirin200MG · capsule;oral	Ribavirin	Discontinued

All 10 submissions, including labeling and manufacturing supplements


Jan 11, 2016	Supplement 20Labeling · Standard review	Approved	None posted
Jul 8, 2014	Supplement 16Labeling · Standard review	Approved	None posted
Jul 8, 2014	Supplement 17Labeling · Standard review	Approved	None posted
Jul 8, 2014	Supplement 18Labeling · Standard review	Approved	None posted
Aug 1, 2011	Supplement 15Labeling	Approved	None posted
Jul 21, 2008	Supplement 12Labeling	Approved	None posted
Jan 4, 2008	Supplement 11Labeling	Approved	None posted
Mar 28, 2006	Supplement 3Labeling	Approved	None posted
Sep 15, 2004	Supplement 1Labeling	Approved	None posted
Apr 6, 2004	Original application	Approved	Label Exclusivity Letter Letter

Identifiers

Application: ANDA 76192
Drugs@FDA: Overview at FDA
Company: Chartwell RX

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