FDA Orange Book · active-ingredient family
Amino acids; calcium chloride; dextrose; magnesium chloride; potassium chloride; potassium phosphate, dibasic; sodium chloride
Amino acids; calcium chloride; dextrose; magnesium chloride; potassium chloride; potassium phosphate, dibasic; sodium chloride is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
2
Brand (NDA)
0
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| AMINOSYN II 3.5% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER×4 | HOSPIRA INC | NDA 019683 | — | Nov 07, 1988 | |
| AMINOSYN II 3.5% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER×4 | ABBOTT | NDA 019714 | — | Sep 12, 1988 |
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; calcium chloride; dextrose; magnesium chloride; potassium chloride; potassium phosphate, dibasic; sodium chloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
