Treats ichthyosis vulgaris and xerosis. ANDA 75774, held by Padagis Israel. Ammonium Lactate.
As of Nov 15, 2026, ANDA 75774 (Ammonium Lactate), held by Padagis Israel, was first approved by FDA on May 1, 2002, with 3 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Ammonium Lactate Cream, 12% is indicated for the treatment of ichthyosis vulgaris and xerosis.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 1, 2002 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ammonium LactateEQ 12% BASE · cream;topical | Ammonium Lactate | Rx |
| Jun 9, 2009 | Supplement 4Labeling | Approved | None posted |
| Dec 26, 2002 | Supplement 2Labeling | Approved | None posted |
| Dec 26, 2002 | Supplement 1Manufacturing | Approved | None posted |
| May 1, 2002 | Original application | 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
