FDA Orange Book · active-ingredient family
Sodium lactate
Sodium lactate is approved in 5 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:SODIUM LACTATE IN PLASTIC CONTAINER · NDA 018947
5
Brand (NDA)
0
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SODIUM LACTATE IN PLASTIC CONTAINERRLD | HOSPIRA | NDA 018947 | — | Sep 05, 1984 | |
| SODIUM LACTATE 1/6 MOLAR IN PLASTIC CONTAINER | B BRAUN | NDA 020004 | — | Apr 21, 1992 | |
| SODIUM LACTATE 0.167 MOLAR IN PLASTIC CONTAINER | B BRAUN | NDA 018186 | — | Approved Prior to Jan 1, 1982 | |
| SODIUM LACTATE 0.167 MOLAR IN PLASTIC CONTAINER | BAXTER HLTHCARE | NDA 016692 | — | Approved Prior to Jan 1, 1982 | |
| SODIUM LACTATE 0.167 MOLAR IN PLASTIC CONTAINER | HOSPIRA | NDA 018249 | — | Approved Prior to Jan 1, 1982 |
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.
Sodium lactate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
