FDA Orange Book · active-ingredient family
Amino acids; magnesium acetate; phosphoric acid; potassium acetate; sodium chloride
Amino acids; magnesium acetate; phosphoric acid; potassium acetate; sodium chloride is approved in 3 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:AMINOSYN 3.5% M IN PLASTIC CONTAINER · NDA 018875
3
Brand (NDA)
0
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| AMINOSYN 3.5% M IN PLASTIC CONTAINER | ABBOTT | NDA 018875 | — | Aug 08, 1984 | |
| AMINOSYN 3.5% M IN PLASTIC CONTAINER | ABBOTT | NDA 018804 | — | May 15, 1984 | |
| AMINOSYN 3.5% M | ICU MEDICAL INC | NDA 017789 | — | 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 acetate; phosphoric acid; potassium acetate; sodium chloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
