FDA Orange Book · active-ingredient family
Dextrose; potassium chloride
Dextrose; potassium chloride is approved as 4 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER · NDA 017634
4
Brand (NDA)
1
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINERRLD×4 | BAXTER HLTHCARE | NDA 017634 | AP | Approved Prior to Jan 1, 1982 | |
| POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% IN PLASTIC CONTAINER×6 | B BRAUN | NDA 019699 | — | Sep 29, 1989 | |
| POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% IN PLASTIC CONTAINER×4 | B BRAUN | NDA 018744 | — | Nov 09, 1982 | |
| POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER×3 | OTSUKA ICU MEDCL | NDA 018371 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (1)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075%×2 | FRESENIUS KABI USA | ANDA 212346 | AP | Sep 10, 2020 |
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.
Dextrose; potassium chloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
