FDA Orange Book · active-ingredient family
Dextrose; magnesium chloride; potassium chloride; sodium acetate; sodium chloride; sodium gluconate
Dextrose; magnesium chloride; potassium chloride; sodium acetate; sodium chloride; sodium gluconate is approved in 4 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:PLASMA-LYTE 148 AND DEXTROSE 5% IN PLASTIC CONTAINER · NDA 017451
4
Brand (NDA)
0
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PLASMA-LYTE 148 AND DEXTROSE 5% IN PLASTIC CONTAINERRLD | BAXTER HLTHCARE | NDA 017451 | — | Approved Prior to Jan 1, 1982 | |
| ISOLYTE S IN DEXTROSE 5% IN PLASTIC CONTAINER | B BRAUN | NDA 019843 | — | Aug 09, 1993 | |
| ISOLYTE S W/ DEXTROSE 5% IN PLASTIC CONTAINER | B BRAUN | NDA 018274 | — | Approved Prior to Jan 1, 1982 | |
| NORMOSOL-R AND DEXTROSE 5% IN PLASTIC CONTAINER | OTSUKA ICU MEDCL | NDA 017609 | — | 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; magnesium chloride; potassium chloride; sodium acetate; sodium chloride; sodium gluconate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
