FDA Orange Book · active-ingredient family
Calcium chloride; dextrose; magnesium chloride; potassium chloride; sodium acetate; sodium chloride
Calcium chloride; dextrose; magnesium chloride; potassium chloride; sodium acetate; sodium chloride is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:ISOLYTE R IN DEXTROSE 5% IN PLASTIC CONTAINER · NDA 019864
2
Brand (NDA)
0
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ISOLYTE R IN DEXTROSE 5% IN PLASTIC CONTAINER | B BRAUN | NDA 019864 | — | Jun 10, 1993 | |
| ISOLYTE R W/ DEXTROSE 5% IN PLASTIC CONTAINER | B BRAUN | NDA 018271 | — | 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.
Calcium chloride; dextrose; magnesium chloride; potassium chloride; sodium acetate; sodium chloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
