Treats ichthyosis vulgaris and xerosis. ANDA 217815, held by Zydus Lifesciences. Ammonium Lactate.
As of Nov 15, 2026, ANDA 217815 (Ammonium Lactate), held by Zydus Lifesciences, was first approved by FDA on Feb 12, 2026, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Ammonium lactate cream is indicated for the treatment of ichthyosis vulgaris and xerosis.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 12, 2026 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ammonium LactateEQ 12% BASE · cream;topical | Ammonium Lactate | Rx |
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
