Manages moderate pruritus. NDA 20126, held by Mylan. Doxepin Hydrochloride.
As of Nov 13, 2026, NDA 20126 (Zonalon), held by Mylan, was first approved by FDA on Apr 1, 1994, with 5 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Zonalon Cream is indicated for the short-term (up to 8 days) management of moderate pruritus in adult patients with atopic dermatitis or lichen simplex chronicus. (See DOSAGE AND ADMINISTRATION.)
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 1, 1994 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Zonalon5% · cream;topical | Doxepin Hydrochloride | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 20, 2002 | Supplement 6Labeling · Standard review | Approved | |
| Aug 1, 1996 | Supplement 4Manufacturing · Standard review | Approved | |
| Jun 29, 1995 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| May 1, 1995 | Supplement 1Manufacturing · Standard review | Approved | |
| Nov 30, 1994 | Supplement 2Manufacturing · Standard review | Approved | |
| Apr 1, 1994 | Original applicationNew dosage form · Standard review | Approved | None posted |
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
