Treats dry, scaly skin (xerosis) and ichthyosis vulgaris. ANDA 76216, held by Sun Pharma Canada. Ammonium Lactate.
As of Nov 15, 2026, ANDA 76216 (Ammonium Lactate), held by Sun Pharma Canada, was first approved by FDA on May 28, 2004, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Ammonium Lactate Lotion is indicated for the treatment of dry, scaly skin (xerosis) and ichthyosis vulgaris and for temporary relief of itching associated with these conditions.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 28, 2004 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ammonium LactateEQ 12% BASE · lotion;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
