FDA Orange Book · active-ingredient family
Amino acids; magnesium chloride; potassium phosphate, dibasic; sodium chloride
Amino acids; magnesium 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.
Reference-listed drug:AMINOSYN 7% W/ ELECTROLYTES · NDA 017789
2
Brand (NDA)
0
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| AMINOSYN 7% W/ ELECTROLYTES | ICU MEDICAL INC | NDA 017789 | — | Approved Prior to Jan 1, 1982 | |
| AMINOSYN 8.5% W/ ELECTROLYTES | ICU MEDICAL INC | NDA 017673 | — | 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.
Amino acids; magnesium 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.
