NDA 21222, held by Vansen Pharma. Cefditoren Pivoxil.
As of Nov 14, 2026, NDA 21222 (Spectracef), held by Vansen Pharma, was first approved by FDA on Aug 29, 2001, with 8 approved supplements and 0 published complete response letters.
| Aug 21, 2002 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Aug 29, 2001 | Original applicationNew molecular entity · Standard review | Approved |
| Spectracef200MG · tablet;oral | Cefditoren Pivoxil | Discontinued |
| Spectracef400MG · tablet;oral | Cefditoren Pivoxil | Discontinued |
| Aug 6, 2012 | Supplement 16Labeling · Standard review | Approved | |
| Aug 6, 2012 | Supplement 13Labeling · Standard review | Approved | |
| Sep 23, 2009 | Supplement 6Labeling · Standard review | Approved | |
| Jul 21, 2008 | Supplement 12Manufacturing · Standard review | Approved | |
| Dec 20, 2005 | Supplement 9Labeling · Standard review | Approved | |
| Mar 23, 2004 | Supplement 3Labeling · Standard review | Approved | |
| Aug 21, 2002 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Jun 11, 2002 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Aug 29, 2001 | Original applicationNew molecular entity · 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
