NDA 21375, held by Fdn Consumer. Loratadine.
As of Nov 14, 2026, NDA 21375 (Alavert), held by Fdn Consumer, was first approved by FDA on Dec 19, 2002, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 19, 2002 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Alavert10MG · tablet, orally disintegrating;oral | Loratadine | OTC |
| Aug 19, 2005 | Supplement 2Manufacturing · Standard review | Approved | |
| Dec 19, 2002 | Original applicationNew dosage form · 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
