Drugs / Ammonium Lactate
Ammonium Lactate
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | LAC-HYDRIN | — | 2000-08-25 | fda.gov ↗ |
| Approved | US (FDA) | LAC-HYDRIN | — | 1985-04-24 | fda.gov ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 31 trial | ||||||
| Phase 3 | NCT04127513 | Apr → May 2017 | — | Indonesia University | Completed | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 4 | NCT00990561 Comparator | Jul 2009 → Jun 2010 | psoriasis | University of California, San Francisco | Completed | No outcome recorded |
| Phase 4 | NCT01111123 Comparator | Jan 2009 → Mar 2010 | psoriasis | Icahn School of Medicine at Mount Sinai | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2026-02-14 | Zydus Lifesciences Limited | Regulatory Zydus receives final approval from USFDA for Ammonium Lactate Cream, 12% zyduslife.com ↗
Zydus Lifesciences Limited (including its subsidiaries/ affiliates, hereafter referred to as “Zydus”) has received final approval from the United States Food and Drug Administration (USFDA) for Ammonium Lactate Cream, 12% (USRLD: Lac-Hydrin Cream®, 12%). |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2026-02-14 | Zydus Lifesciences Limited | Zydus receives final approval from USFDA for Ammonium Lactate Cream, 12% zyduslife.com ↗ |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ammonium lactate | “This is an investigator-masked, randomized, parallel, clinical study comparing the efficacy of once daily versus twice daily application of Ultravate® ointment (halobetasol...” NCT00990561 ↗ |
| Known as | BMS-186091 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200747 ↗ |
| Known as | E328 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200747 ↗ |
| Known as | Lac-Hydrin | “This is an investigator-masked, randomized, parallel, clinical study comparing the efficacy of once daily versus twice daily application of Ultravate® ointment (halobetasol...” NCT00990561 ↗ |
| Known as | NSC-760427 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200747 ↗ |
| Modality | Small molecule | — CHEMBL1200747 ↗ |
| Route | Topical | “Patients will apply both Ultravate ointment and LacHydrin lotion twice daily” NCT00990561 ↗ |