Treats ichthyosis vulgaris and xerosis. ANDA 75883, held by Sun Pharma Canada. Ammonium Lactate.
As of Nov 15, 2026, ANDA 75883 (Ammonium Lactate), held by Sun Pharma Canada, was first approved by FDA on Apr 10, 2003, with 1 approved supplement 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 |
|---|---|---|---|
| Apr 10, 2003 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ammonium LactateEQ 12% BASE · cream;topical | Ammonium Lactate | Rx |
| Jul 30, 2004 | Supplement 2Labeling | Approved | None posted |
| Apr 10, 2003 | 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
