NDA 20119, held by Hq Speclt Pharma. Teniposide.
As of Nov 13, 2026, NDA 20119 (Vumon), held by Hq Speclt Pharma, was first approved by FDA on Jul 14, 1992, with 11 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 14, 1992 | Original applicationNew molecular entity · Priority review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Vumon10MG/ML · injectable;injection | Teniposide | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 2, 2015 | Supplement 13Labeling · Standard review | Approved | |
| Feb 26, 2013 | Supplement 12Manufacturing · Priority review | Approved | None posted |
| Oct 20, 2011 | Supplement 10Labeling · Standard review | Approved | |
| Oct 20, 2011 | Supplement 11Labeling | Approved | |
| Feb 10, 2009 | Supplement 9Labeling · Standard review | Approved | |
| Oct 1, 2002 | Supplement 4Labeling · Standard review | Approved | |
| Jan 28, 2000 | Supplement 7Manufacturing · Priority review | Approved | None posted |
| Aug 17, 1998 | Supplement 6Manufacturing · Priority review | Approved | None posted |
| Sep 5, 1997 | Supplement 5Manufacturing · Priority review | Approved | None posted |
| Mar 3, 1994 | Supplement 2Manufacturing · Priority review | Approved | None posted |
| Sep 28, 1992 | Supplement 1Manufacturing · Priority review | Approved | None posted |
| Jul 14, 1992 | Original applicationNew molecular entity · Priority review | Approved | None posted |
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
