FDA Orange Book · active-ingredient family
Amino acids
Amino acids is approved as 26 brand and 5 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:PROSOL 20% SULFITE FREE IN PLASTIC CONTAINER · NDA 020849
26
Brand (NDA)
5
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PROSOL 20% SULFITE FREE IN PLASTIC CONTAINERRLD | BAXTER HLTHCARE | NDA 020849 | — | Aug 26, 1998 | |
| TROPHAMINERLD×2 | B BRAUN | NDA 019018 | — | Jul 20, 1984 | |
| NOVAMINE 15% SULFITE FREE IN PLASTIC CONTAINER | BAXTER HLTHCARE | NDA 020107 | — | Feb 05, 1993 | |
| AMINOSYN II 10% IN PLASTIC CONTAINER | OTSUKA ICU MEDCL | NDA 020015 | — | Dec 19, 1991 | |
| AMINOSYN II 15% IN PLASTIC CONTAINER | OTSUKA ICU MEDCL | NDA 020041 | — | Dec 19, 1991 | |
| AMINOSYN-PF 10% | OTSUKA ICU MEDCL | NDA 019492 | — | Oct 17, 1986 | |
| AMINOSYN II 3.5% IN PLASTIC CONTAINER | ABBOTT | NDA 019491 | — | Oct 10, 1986 | |
| AMINOSYN-HBC 7% IN PLASTIC CONTAINER | ABBOTT | NDA 019400 | — | Jul 23, 1986 | |
| AMINOSYN II 10%×5 | ICU MEDICAL INC | NDA 019438 | — | Apr 03, 1986 | |
| AMINOSYN-PF 7% | OTSUKA ICU MEDCL | NDA 019398 | — | Sep 06, 1985 | |
| AMINOSYN-HBC 7% | ICU MEDICAL INC | NDA 019374 | — | Jul 12, 1985 | |
| BRANCHAMIN 4% | BAXTER HLTHCARE | NDA 018678 | — | Sep 28, 1984 | |
| BRANCHAMIN 4% IN PLASTIC CONTAINER | BAXTER HLTHCARE | NDA 018684 | — | Sep 28, 1984 | |
| TRAVASOL 10% IN PLASTIC CONTAINER×3 | BAXTER HLTHCARE | NDA 018931 | — | Aug 23, 1984 | |
| AMINOSYN 3.5% IN PLASTIC CONTAINER | ABBOTT | NDA 018875 | — | Aug 08, 1984 | |
| AMINOSYN 3.5% IN PLASTIC CONTAINER | ABBOTT | NDA 018804 | — | May 15, 1984 | |
| AMINESS 5.2% ESSENTIAL AMINO ACIDS W/ HISTADINE | HOSPIRA | NDA 018901 | — | Apr 06, 1984 | |
| NEOPHAM 6.4% | HOSPIRA | NDA 018792 | — | Jan 17, 1984 | |
| RENAMIN W/O ELECTROLYTES×4 | BAXTER HLTHCARE | NDA 017493 | — | Oct 15, 1982 | |
| NOVAMINE 11.4%×3 | HOSPIRA INC | NDA 017957 | — | Aug 09, 1982 | |
| HEPATAMINE 8% | B BRAUN | NDA 018676 | — | Aug 03, 1982 | |
| AMINOSYN 10%×7 | ICU MEDICAL INC | NDA 017673 | — | Approved Prior to Jan 1, 1982 | |
| AMINOSYN 3.5% | ICU MEDICAL INC | NDA 017789 | — | Approved Prior to Jan 1, 1982 | |
| AMINOSYN-RF 5.2% | ICU MEDICAL INC | NDA 018429 | — | Approved Prior to Jan 1, 1982 | |
| FREAMINE 8.5%×5 | B BRAUN | NDA 016822 | — | Approved Prior to Jan 1, 1982 | |
| NEPHRAMINE 5.4% | B BRAUN | NDA 017766 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (5)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| AMINO ACIDS×2 | B BRAUN | ANDA 091112 | — | Apr 13, 2012 | |
| PREMASOL 10% IN PLASTIC CONTAINER×2 | BAXTER HLTHCARE | ANDA 075880 | — | Jun 19, 2003 | |
| CLINISOL 15% SULFITE FREE IN PLASTIC CONTAINER | BAXTER HLTHCARE | ANDA 020512 | — | Aug 30, 1996 | |
| AMINOSYN-HF 8% | ICU MEDICAL INC | ANDA 020345 | — | Apr 04, 1996 | |
| HEPATASOL 8% | BAXTER HLTHCARE | ANDA 020360 | — | Apr 04, 1996 |
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 — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
