NDA 20625, held by Chattem Sanofi. Fexofenadine Hydrochloride.
As of Nov 14, 2026, NDA 20625 (Allegra), held by Chattem Sanofi, was first approved by FDA on Jul 25, 1996, with 10 approved supplements and 0 published complete response letters.
| May 12, 2003 | Supplement 10Efficacy (new indication or use) · Standard review | Approved | |
| May 12, 2003 | Supplement 12Efficacy (new indication or use) · Priority review | Approved | |
| Jul 25, 1996 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Allegra60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule;oral | Fexofenadine Hydrochloride | Discontinued |
| May 12, 2003 | Supplement 10Efficacy (new indication or use) · Standard review | Approved | |
| May 12, 2003 | Supplement 12Efficacy (new indication or use) · Priority review | Approved | |
| Jul 11, 2001 | Supplement 11Labeling · Standard review | Approved | |
| Jan 21, 2000 | Supplement 8Manufacturing · Standard review | Approved | |
| Jan 6, 2000 | Supplement 9Manufacturing · Standard review | Approved | |
| Dec 22, 1998 | Supplement 7Labeling · Standard review | Approved | |
| Jul 6, 1998 | Supplement 6Manufacturing · Standard review | Approved | |
| Jan 29, 1998 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Jan 28, 1997 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Oct 16, 1996 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Jul 25, 1996 | 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
