ANDA 77094, held by Zydus Pharms USA. Ribavirin.
As of Nov 14, 2026, ANDA 77094 (Ribavirin), held by Zydus Pharms USA, was first approved by FDA on Dec 5, 2005, with 15 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 5, 2005 | Original application | Approved |
| Sep 25, 2015 | Supplement 23Labeling · Standard review | Approved | None posted |
| May 4, 2015 | Supplement 21Labeling · Standard review | Approved | None posted |
| May 4, 2015 | Supplement 20Labeling | Approved | None posted |
| Sep 11, 2014 | Supplement 7Labeling | Approved | None posted |
| Nov 10, 2011 | Supplement 19REMS | Approved | None posted |
| Mar 10, 2011 | Supplement 18REMS | Approved | None posted |
| Sep 16, 2010 | Supplement 17Labeling | Approved | None posted |
| Jul 23, 2008 | Supplement 15Labeling | Approved | None posted |
| May 14, 2008 | Supplement 14Labeling | Approved | None posted |
| Apr 18, 2008 | Supplement 11Labeling | Approved | None posted |
| Mar 20, 2008 | Supplement 6Manufacturing | Approved | None posted |
| Jan 4, 2008 | Supplement 12Labeling | Approved | None posted |
| Mar 16, 2007 | Supplement 2Labeling | Approved | None posted |
| Mar 16, 2007 | Supplement 1Manufacturing | Approved | None posted |
| Jan 10, 2007 | Supplement 5Labeling | Approved | None posted |
| Dec 5, 2005 | Original application | Approved |
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
