FDA Orange Book · active-ingredient family
Ammonium lactate
Ammonium lactate is approved as 2 brand and 8 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:LAC-HYDRIN · NDA 020508
2
Brand (NDA)
8
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · cream, lotion
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LAC-HYDRINRLD | SUN PHARM INDS INC | NDA 020508 | — | Aug 29, 1996 | |
| LAC-HYDRINRLD | SUN PHARM INDS INC | NDA 019155 | — | Apr 24, 1985 |
Generic (ANDA) products (8)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| AMMONIUM LACTATE | ZYDUS LIFESCIENCES | ANDA 217758 | AB | May 15, 2026 | |
| AMMONIUM LACTATE | ZYDUS LIFESCIENCES | ANDA 217815 | AB | Feb 12, 2026 | |
| AMMONIUM LACTATE | WATSON LABS INC | ANDA 076829 | — | Feb 07, 2006 | |
| AMMONIUM LACTATE | PADAGIS ISRAEL | ANDA 075570 | AB | Jun 23, 2004 | |
| AMMONIUM LACTATE | SUN PHARMA CANADA | ANDA 076216 | AB | May 28, 2004 | |
| AMMONIUM LACTATE | SUN PHARMA CANADA | ANDA 075883 | AB | Apr 10, 2003 | |
| AMMONIUM LACTATE | WATSON LABS INC | ANDA 075575 | — | Jun 11, 2002 | |
| AMMONIUM LACTATE | PADAGIS ISRAEL | ANDA 075774 | AB | May 01, 2002 |
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.
Ammonium lactate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
