FDA Orange Book · active-ingredient family
Amino acids; dextrose
Amino acids; dextrose is approved in 11 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:CLINIMIX 2.75/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER · NDA 020734
11
Brand (NDA)
0
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CLINIMIX 2.75/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER×13 | BAXTER HLTHCARE | NDA 020734 | — | Sep 29, 1997 | |
| AMINOSYN II 3.5% IN DEXTROSE 25% IN PLASTIC CONTAINER×6 | HOSPIRA | NDA 019681 | — | Nov 01, 1988 | |
| TRAVASOL 2.75% IN DEXTROSE 10% IN PLASTIC CONTAINER×10 | BAXTER HLTHCARE | NDA 019520 | — | Sep 23, 1988 | |
| AMINOSYN II 3.5% IN DEXTROSE 25% IN PLASTIC CONTAINER×6 | ABBOTT | NDA 019713 | — | Sep 09, 1988 | |
| AMINOSYN II 5% IN DEXTROSE 25% IN PLASTIC CONTAINER | ABBOTT | NDA 019565 | — | Dec 17, 1986 | |
| AMINOSYN II 3.5% IN DEXTROSE 25% IN PLASTIC CONTAINER | ABBOTT | NDA 019505 | — | Nov 07, 1986 | |
| AMINOSYN II 3.5% IN DEXTROSE 5% IN PLASTIC CONTAINER | ABBOTT | NDA 019506 | — | Nov 07, 1986 | |
| AMINOSYN II 4.25% IN DEXTROSE 25% IN PLASTIC CONTAINER | ABBOTT | NDA 019504 | — | Nov 07, 1986 | |
| AMINOSYN 3.5% W/ DEXTROSE 25% IN PLASTIC CONTAINER | ABBOTT | NDA 019118 | — | Oct 11, 1984 | |
| AMINOSYN 3.5% W/ DEXTROSE 5% IN PLASTIC CONTAINER | ABBOTT | NDA 019120 | — | Oct 11, 1984 | |
| AMINOSYN 4.25% W/ DEXTROSE 25% IN PLASTIC CONTAINER | ABBOTT | NDA 019119 | — | Oct 11, 1984 |
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 — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
