Ribavirin

ANDA 77456, held by Chartwell Rx. Ribavirin.

As of Nov 14, 2026, ANDA 77456 (Ribavirin), held by Chartwell Rx, was first approved by FDA on Dec 5, 2005, with 10 approved supplements and 0 published complete response letters.

First approved: Dec 5, 2005
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Dec 5, 2005	Original application	Approved	None posted

Products

3 strengths and forms


Ribavirin200MG · tablet;oral	Ribavirin	Discontinued
Ribavirin400MG · tablet;oral	Ribavirin	Discontinued
Ribavirin600MG · tablet;oral	Ribavirin	Discontinued

All 11 submissions, including labeling and manufacturing supplements


Sep 18, 2017	Supplement 21Labeling · Standard review	Approved	None posted
Feb 6, 2015	Supplement 17Labeling · Standard review	Approved	None posted
Apr 9, 2014	Supplement 14Manufacturing	Approved	None posted
May 23, 2011	Supplement 12Labeling	Approved	None posted
Mar 29, 2011	Supplement 10Manufacturing	Approved	None posted
Oct 27, 2010	Supplement 11Labeling	Approved	None posted
May 21, 2009	Supplement 6Labeling	Approved	None posted
Jun 18, 2008	Supplement 7Manufacturing	Approved	None posted
Feb 11, 2008	Supplement 8Labeling	Approved	None posted
Feb 6, 2006	Supplement 3Labeling	Approved	None posted
Dec 5, 2005	Original application	Approved	None posted

Identifiers

Application: ANDA 77456
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