FDA Orange Book · active-ingredient family
Calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate
Calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate is approved as 7 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
7
Brand (NDA)
2
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINERRLD×8 | OTSUKA ICU MEDCL | NDA 019685 | — | Oct 17, 1988 | |
| DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINERRLD | OTSUKA ICU MEDCL | NDA 017608 | AP | Approved Prior to Jan 1, 1982 | |
| DEXTROSE 2.5% IN HALF-STRENGTH LACTATED RINGER'S IN PLASTIC CONTAINER×3 | B BRAUN | NDA 019634 | — | Feb 24, 1988 | |
| POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER×8 | BAXTER HLTHCARE | NDA 019367 | — | Apr 05, 1985 | |
| DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER | B BRAUN | NDA 017510 | — | Approved Prior to Jan 1, 1982 | |
| DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER | MILES | NDA 018499 | — | Approved Prior to Jan 1, 1982 | |
| LACTATED RINGER'S AND DEXTROSE 5% IN PLASTIC CONTAINER | BAXTER HLTHCARE | NDA 016679 | AP | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (2)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DEXTROSE 5% AND LACTATED RINGER'S | FRESENIUS KABI USA | ANDA 210332 | AP | Mar 28, 2022 | |
| POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER | FRESENIUS KABI USA | ANDA 211428 | — | Nov 09, 2021 |
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; dextrose; 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.
