Orange Book product · Brand (NDA)
LAC-HYDRIN
AMMONIUM LACTATE
At a glance
Aug 29, 1996
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 29, 1996
30 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
AMMONIUM LACTATE
Strength
EQ 12% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
CREAM
Route
TOPICAL
TE code
Not listed
Application
NDA 020508
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 1985LAC-HYDRINBrand (NDA)
NDA 019155 · SUN PHARM INDS INC
- 2026AMMONIUM LACTATEGeneric (ANDA)
ANDA 217758 · ZYDUS LIFESCIENCES
- 2026AMMONIUM LACTATEGeneric (ANDA)
ANDA 217815 · ZYDUS LIFESCIENCES
- 2006AMMONIUM LACTATEGeneric (ANDA)
ANDA 076829 · WATSON LABS INC
- 2004AMMONIUM LACTATEGeneric (ANDA)
ANDA 075570 · PADAGIS ISRAEL
- 2004AMMONIUM LACTATEGeneric (ANDA)
ANDA 076216 · SUN PHARMA CANADA
- 2003AMMONIUM LACTATEGeneric (ANDA)
ANDA 075883 · SUN PHARMA CANADA
- 2002AMMONIUM LACTATEGeneric (ANDA)
ANDA 075575 · WATSON LABS INC
- 2002AMMONIUM LACTATEGeneric (ANDA)
ANDA 075774 · PADAGIS ISRAEL
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
