NDA 20716, held by Abbvie. Hydrocodone Bitartrate; Ibuprofen.
As of Nov 13, 2026, NDA 20716 (Vicoprofen), held by Abbvie, was first approved by FDA on Sep 23, 1997, with 13 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 23, 1997 | Original applicationNew combination · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Vicoprofen7.5MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Hydrocodone Bitartrate; Ibuprofen | DiscontinuedReference drug |
| Dec 16, 2016 | Supplement 12Labeling · Standard review | Approved | |
| Dec 16, 2016 | Supplement 13Labeling · Standard review | Approved | |
| Dec 16, 2016 | Supplement 14Labeling · Standard review | Approved | |
| Dec 16, 2016 | Supplement 15Labeling · Standard review | Approved | |
| Dec 16, 2016 | Supplement 16Labeling · Standard review | Approved | |
| Aug 27, 2012 | Supplement 11Labeling · Standard review | Approved | |
| Jul 25, 2008 | Supplement 10Labeling · Standard review | Approved | |
| Oct 26, 2006 | Supplement 8Labeling · Standard review | Approved | |
| Dec 2, 2002 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Dec 13, 2001 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Feb 13, 2001 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Mar 14, 2000 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Jun 17, 1998 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Sep 23, 1997 | Original applicationNew combination · Standard review | 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
