FDA Orange Book · active-ingredient family
Amino acids; calcium chloride; dextrose; magnesium sulfate; potassium chloride; sodium acetate; sodium glycerophosphate; soybean oil
Amino acids; calcium chloride; dextrose; magnesium sulfate; potassium chloride; sodium acetate; sodium glycerophosphate; soybean oil is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:KABIVEN IN PLASTIC CONTAINER · NDA 200656
1
Brand (NDA)
0
Generics (ANDA)
1
Listed patents
0
Exclusivity periods
Brand (NDA) products · emulsion
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| KABIVEN IN PLASTIC CONTAINERRLD×7 | FRESENIUS KABI USA | NDA 200656 | — | Aug 25, 2014 |
Listed patents (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| 12390398 | May 03, 2036 | in 10 yr | Product |
Amino acids; calcium chloride; dextrose; magnesium sulfate; potassium chloride; sodium acetate; sodium glycerophosphate; soybean oil — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
