Treats dry, scaly skin (xerosis) and ichthyosis vulgaris. ANDA 75570, held by Padagis Israel. Ammonium Lactate.
As of Nov 15, 2026, ANDA 75570 (Ammonium Lactate), held by Padagis Israel, was first approved by FDA on Jun 23, 2004, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE Ammonium Lactate Lotion, 12% is indicated for the treatment of dry, scaly skin (xerosis) and ichthyosis vulgaris, and for the temporary relief of itching associated with these conditions.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 23, 2004 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ammonium LactateEQ 12% BASE · lotion;topical | Ammonium Lactate | Rx |
| Jun 9, 2009 | Supplement 1Labeling | Approved | None posted |
| Jun 23, 2004 | 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
