FDA Orange Book · active-ingredient family
Dextrose; magnesium chloride; potassium chloride; potassium phosphate, monobasic; sodium lactate; sodium phosphate, monobasic anhydrous
Dextrose; magnesium chloride; potassium chloride; potassium phosphate, monobasic; sodium lactate; sodium phosphate, monobasic anhydrous is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:IONOSOL MB AND DEXTROSE 5% IN PLASTIC CONTAINER · NDA 019513
1
Brand (NDA)
0
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| IONOSOL MB AND DEXTROSE 5% IN PLASTIC CONTAINER | OTSUKA ICU MEDCL | NDA 019513 | — | May 08, 1986 |
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, monobasic; sodium lactate; sodium phosphate, monobasic anhydrous — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
