FDA — authorised 24 April 1985
- Application: NDA019155
- Marketing authorisation holder: SUN PHARM INDS INC
- Local brand name: LAC-HYDRIN
- Indication: LOTION — TOPICAL
- Status: approved
🇺🇸 Lac-Hydrin in United States
FDA authorised Lac-Hydrin on 24 April 1985
Marketing authorisations
FDA — authorised 29 August 1996
- Application: NDA020508
- Marketing authorisation holder: SUN PHARM INDS INC
- Local brand name: LAC-HYDRIN
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 1 May 2002
- Application: ANDA075774
- Marketing authorisation holder: PADAGIS ISRAEL
- Local brand name: AMMONIUM LACTATE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 11 June 2002
- Application: ANDA075575
- Marketing authorisation holder: WATSON LABS INC
- Local brand name: AMMONIUM LACTATE
- Indication: LOTION — TOPICAL
- Status: approved
FDA — authorised 10 April 2003
- Application: ANDA075883
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: AMMONIUM LACTATE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 28 May 2004
- Application: ANDA076216
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: AMMONIUM LACTATE
- Indication: LOTION — TOPICAL
- Status: approved
FDA — authorised 23 June 2004
- Application: ANDA075570
- Marketing authorisation holder: PADAGIS ISRAEL
- Local brand name: AMMONIUM LACTATE
- Indication: LOTION — TOPICAL
- Status: approved
FDA — authorised 7 February 2006
- Application: ANDA076829
- Marketing authorisation holder: WATSON LABS INC
- Local brand name: AMMONIUM LACTATE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 12 February 2026
- Application: ANDA217815
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Local brand name: AMMONIUM LACTATE
- Indication: CREAM — TOPICAL
- Status: approved
The FDA approved Lac-Hydrin (Ammonium Lactate) cream for topical use on 12 February 2026. This approval was granted to ZYDUS LIFESCIENCES under the standard expedited pathway. Lac-Hydrin is indicated for the treatment of dry skin conditions. The approval was based on an application number of ANDA217815.
Lac-Hydrin in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Lac-Hydrin approved in United States?
Yes. FDA authorised it on 24 April 1985; FDA authorised it on 29 August 1996; FDA authorised it on 1 May 2002.
Who is the marketing authorisation holder for Lac-Hydrin in United States?
SUN PHARM INDS INC holds the US marketing authorisation.