FDA Orange Book · active-ingredient family
Amino acids; dextrose; magnesium chloride; potassium chloride; sodium chloride; sodium phosphate, dibasic, heptahydrate
Amino acids; dextrose; magnesium chloride; potassium chloride; sodium chloride; sodium phosphate, dibasic, heptahydrate is approved in 3 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER · NDA 019682
3
Brand (NDA)
0
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER×2 | HOSPIRA INC | NDA 019682 | — | Nov 01, 1988 | |
| AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER | ABBOTT | NDA 019712 | — | Sep 08, 1988 | |
| AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER×2 | ABBOTT | NDA 019564 | — | Dec 16, 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.
Amino acids; dextrose; magnesium chloride; potassium chloride; sodium chloride; sodium phosphate, dibasic, heptahydrate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
