FDA Orange Book · active-ingredient family
Potassium chloride; sodium chloride
Potassium chloride; sodium chloride is approved as 4 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45% · NDA 017648
4
Brand (NDA)
2
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45%RLD×5 | BAXTER HLTHCARE | NDA 017648 | AP | Nov 26, 2002 | |
| POTASSIUM CHLORIDE 0.037% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER×6 | B BRAUN | NDA 019708 | — | Sep 29, 1989 | |
| POTASSIUM CHLORIDE 20MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER×2 | OTSUKA ICU MEDCL | NDA 019686 | AP | Oct 17, 1988 | |
| SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER×4 | B BRAUN | NDA 018722 | — | Nov 09, 1982 |
Generic (ANDA) products (2)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45%×3 | FRESENIUS KABI USA | ANDA 212347 | AP | Sep 17, 2020 | |
| POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | OTSUKA ICU MEDCL | ANDA 078446 | AP | Sep 10, 2008 |
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.
Potassium chloride; sodium chloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
