FDA Orange Book · active-ingredient family
Dextrose; magnesium chloride; potassium chloride; potassium phosphate, dibasic; sodium acetate
Dextrose; magnesium chloride; potassium chloride; potassium phosphate, dibasic; sodium acetate is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:ISOLYTE P IN DEXTROSE 5% IN PLASTIC CONTAINER · NDA 019873
2
Brand (NDA)
0
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ISOLYTE P IN DEXTROSE 5% IN PLASTIC CONTAINER | B BRAUN | NDA 019873 | — | Jun 10, 1993 | |
| ISOLYTE P W/ DEXTROSE 5% IN PLASTIC CONTAINER | B BRAUN | NDA 019025 | — | Dec 27, 1984 |
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; magnesium chloride; potassium chloride; potassium phosphate, dibasic; sodium acetate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
