FDA Orange Book · active-ingredient family
Dextrose; potassium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride
Dextrose; potassium chloride; potassium phosphate, dibasic; 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 M IN DEXTROSE 5% IN PLASTIC CONTAINER · NDA 019870
2
Brand (NDA)
0
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ISOLYTE M IN DEXTROSE 5% IN PLASTIC CONTAINER | B BRAUN | NDA 019870 | — | Jun 10, 1993 | |
| ISOLYTE M W/ DEXTROSE 5% IN PLASTIC CONTAINER | B BRAUN | NDA 018270 | — | 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.
Dextrose; potassium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
