Ammonium lactate
As of the edition of 20 October 2026, Ammonium lactate is a small molecule: marketed, first approved in 1985 (US); no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1985
- Kind
- Small molecule
- Brand name
- Lac-Hydrin
- First approved
- 24 April 1985 (US)
- Approvals on record
- 2 in 1 region
- Holder of the most recent approval
- SUN Pharmaceutical Industries
- Registered trials
- 1, 0 stopped early
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this drug.
This is the US only.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 3 | 1 | 1 | 0 | 0 |
| All trials | 1 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bristol Myers Squibb | Earlier holder | 1985 to now |
| Westwood Squibb Pharmaceuticals | Later holder | 1996 to now |
| SUN Pharmaceutical Industries | Acquired holder | 2018 to now |