FDA Orange Book · active-ingredient family
Calcium chloride; potassium chloride; sodium chloride; sodium lactate
Calcium chloride; potassium chloride; sodium chloride; sodium lactate is approved as 11 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:LACTATED RINGER'S IN PLASTIC CONTAINER · NDA 019416
11
Brand (NDA)
1
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable, solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LACTATED RINGER'S IN PLASTIC CONTAINERRLD | OTSUKA ICU MEDCL | NDA 019416 | AT | Jan 17, 1986 | |
| LACTATED RINGER'S IN PLASTIC CONTAINERRLD | BAXTER HLTHCARE | NDA 018921 | AT | Apr 03, 1984 | |
| LACTATED RINGER'S IN PLASTIC CONTAINERRLD | B BRAUN | NDA 018681 | AT | Dec 27, 1982 | |
| LACTATED RINGER'S IN PLASTIC CONTAINERRLD | BAXTER HLTHCARE | NDA 016682 | AP | Approved Prior to Jan 1, 1982 | |
| LACTATED RINGER'S IN PLASTIC CONTAINER | BAXTER HLTHCARE | NDA 019933 | — | Aug 29, 1989 | |
| LACTATED RINGER'S IN PLASTIC CONTAINER | B BRAUN | NDA 019632 | AP | Feb 29, 1988 | |
| LACTATED RINGER'S IN PLASTIC CONTAINER | ABBOTT | NDA 019485 | — | Oct 24, 1985 | |
| LACTATED RINGER'S IN PLASTIC CONTAINER | BAXTER HLTHCARE | NDA 018494 | AT | Feb 19, 1982 | |
| LACTATED RINGER'S IN PLASTIC CONTAINER | B BRAUN | NDA 018023 | — | Approved Prior to Jan 1, 1982 | |
| LACTATED RINGER'S IN PLASTIC CONTAINER | MILES | NDA 018417 | — | Approved Prior to Jan 1, 1982 | |
| LACTATED RINGER'S IN PLASTIC CONTAINER | OTSUKA ICU MEDCL | NDA 017641 | AP | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (1)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LACTATED RINGER'S IN PLASTIC CONTAINER | FRESENIUS KABI USA | ANDA 209338 | AP | Jan 28, 2019 |
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.
Calcium chloride; potassium chloride; sodium chloride; sodium lactate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
