ANDA 217758, held by Zydus Lifesciences. Ammonium Lactate.
As of Nov 15, 2026, ANDA 217758 (Ammonium Lactate), held by Zydus Lifesciences, was first approved by FDA on May 15, 2026, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 15, 2026 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ammonium LactateEQ 12% BASE ยท 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
