FDA Orange Book · active-ingredient family
Amino acids; dextrose; magnesium chloride; potassium acetate; potassium chloride; potassium phosphate, dibasic; sodium chloride
Amino acids; dextrose; magnesium chloride; potassium acetate; 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 4.25% W/ ELECT AND ADJUSTED PHOSPHATE IN DEXTROSE 10% IN PLASTIC CONTAINER | HOSPIRA INC | NDA 019682 | — | Nov 01, 1988 | |
| AMINOSYN II 4.25% W/ ELECT AND ADJUSTED PHOSPHATE IN DEXTROSE 10% IN PLASTIC CONTAINER | ABBOTT | NDA 019712 | — | Sep 08, 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; dextrose; magnesium chloride; potassium acetate; 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.
