NDA 20934, held by Quagen. Betamethasone Valerate.
As of Nov 13, 2026, NDA 20934 (Luxiq), held by Quagen, was first approved by FDA on Feb 28, 1999, with 10 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 28, 1999 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Luxiq0.12% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · aerosol, foam;topical | Betamethasone Valerate | DiscontinuedReference drug |
| Jul 11, 2006 | Supplement 16Labeling · Standard review | Approved | |
| Jun 16, 2006 | Supplement 15Manufacturing | Approved | None posted |
| Dec 29, 2003 | Supplement 12Manufacturing · Standard review | Approved | |
| Oct 31, 2003 | Supplement 11Labeling · Standard review | Approved | |
| Nov 3, 2002 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Oct 9, 2002 | Supplement 6Manufacturing · Standard review | Approved | |
| Oct 8, 2002 | Supplement 7Manufacturing · Standard review | Approved | |
| May 6, 2002 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Feb 28, 2002 | Supplement 4Manufacturing · Standard review | Approved | |
| Nov 12, 2000 | Supplement 1Labeling · Standard review | Approved | None posted |
| Feb 28, 1999 | 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
