Amino Acids

For extensive burns. Sold as Freamine 8.5%, Freamine Ii 8.5%, Freamine Iii 8.5%, Freamine Iii 10%, Freamine Hbc 6.9% and 39 more. Every FDA application for this active ingredient: 26 branded and 5 generic.

As of Nov 15, 2026, FDA lists 31 applications for Amino Acids (sold as Freamine 8.5%, Freamine Ii 8.5%, Freamine Iii 8.5% and others), first approved Sep 24, 1971, with 2 new uses approved and 0 published complete response letters.

First approved: Sep 24, 1971
Applications: 31
New uses approved: 2
Complete response letters: 0
First approved in the EU: Jul 28, 2025
Shortage: Current

Approvals in the EU (EMA)

First approved in the EU 646 months after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Maapliv, new substanceRecordati Rare Diseases · Jul 28, 2025

Shortages

FDA's drug shortage list, as of Nov 13, 2026

Shortage	Status	First posted	Updated
Amino Acid Injection	Current	Dec 8, 2020	Nov 10, 2026

Clinical Trials

5,695 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Topical Lactoferrin and Luliconazole, Alone or in Combination, for Tinea CorporisTinea Corporis · Kafrelsheikh University	Not applicable	Recruiting	Nov 13, 2026
Phase 2 Study of GC4006A in Healthy AdultsCovid-19 Prevention · GC Biopharma Corp	Phase 2	Enrolling by invitation	Nov 13, 2026
Asciminib and Inotuzumab Ozogamicin for Relapsed or Refractory Philadelphia Chromosome-positive B-cell Acute Lymphoblastic Leukemia (R/R Ph+ B-ALL)B-cell Acute Lymphoblastic Leukemia (B-ALL) · Sunil G. Iyer	Phase 1	Recruiting	Nov 13, 2026
Effects of a Gut-Active Peptide That Stimulates GLP-1 Release on Appetite and Satiety in Healthy Adults With OverweightAppetite and Hunger, Suppression, Satiety and Appetite · Lembas	Not applicable	Not yet recruiting	Nov 13, 2026
Gut Microbiota and Amino Acid Metabolism in Post-CPB Delayed Neurocognitive RecoveryDelayed Neurocognitive Recovery, Cardiopulmonary Bypass · XiaoLiang Wang	—	Recruiting	Nov 13, 2026
Repurposing Insulin With Intranasal Administration to Improve Function After Mild Traumatic Brain InjuryConcussion (Diagnosis), Mild Traumatic Brain Injury · HealthPartners Institute	Phase 2	Recruiting	Nov 13, 2026
Prolonged Multimodal Analgesia for Postsurgical PainAcute and Chronic Postsurgical Pain · Beijing Tiantan Hospital	Not applicable	Not yet recruiting	Nov 13, 2026
Phase I Trial of Subcutaneous VDJ010 In Healthy Subjects and Patients With Ulcerative ColitisUlcerative Colitis (UC) · Beijing VDJBio Co., LTD.	Phase 1	Recruiting	Nov 12, 2026

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Sep 24, 1971	Freamine 8.5%, Freamine Ii 8.5%NDA 16822 · New combination	B Braun	62	Discontinued
Dec 3, 1975	Aminosyn 5%, Aminosyn 7%NDA 17673 · New dosage form	Icu Medical Inc	67	Discontinued
Mar 24, 1976	Travasol 5.5% W/ Electrolytes, Travasol 8.5% W/ ElectrolytesNDA 17493 · New formulation or manufacturer	Baxter Hlthcare	59	Discontinued
May 14, 1976	Aminosyn 7% W/ Electrolytes, Aminosyn 3.5% MNDA 17789 · New dosage form	Icu Medical Inc	47	Discontinued
Jan 3, 1978	Veinamine 8%, Novamine 8.5%NDA 17957 · New dosage form	Hospira Inc	30	Discontinued
Feb 24, 1978	Nephramine 5.4%NDA 17766 · New formulation or manufacturer	B Braun	30	Discontinued
Nov 28, 1980	Aminosyn-Rf 5.2%NDA 18429 · New dosage form	Icu Medical Inc	17	Discontinued
Aug 3, 1982	Hepatamine 8%NDA 18676 · New dosage form	B Braun	22	Discontinued
Jan 17, 1984	Neopham 6.4%NDA 18792 · New dosage form	Hospira	10	Discontinued
Apr 6, 1984	Aminess 5.2% Essential Amino Acids W/ HistadineNDA 18901 · New formulation or manufacturer	Hospira	12	Discontinued
Jul 20, 1984	Trophamine, Trophamine 10%NDA 19018 · New formulation or manufacturer	B Braun	20	Marketed
Aug 23, 1984	Travasol 5.5% In Plastic Container, Travasol 8.5% In Plastic ContainerNDA 18931 · New formulation or manufacturer	Baxter Hlthcare	37	Marketed
Sep 28, 1984	Branchamin 4% In Plastic ContainerNDA 18684 · New dosage form	Baxter Hlthcare	16	Discontinued
Jul 12, 1985	Aminosyn-Hbc 7%NDA 19374 · New formulation or manufacturer	Icu Medical Inc	14	Discontinued
Sep 6, 1985	Aminosyn-Pf 7%NDA 19398 · New formulation or manufacturer	Otsuka Icu Medcl	16	Marketed
Apr 3, 1986	Aminosyn Ii 3.5%, Aminosyn Ii 5%NDA 19438 · New formulation or manufacturer	Icu Medical Inc	13	Discontinued
Oct 17, 1986	Aminosyn-Pf 10%NDA 19492 · New dosage form	Otsuka Icu Medcl	15	Marketed
Dec 19, 1991	Aminosyn Ii 10% In Plastic ContainerNDA 20015 · New formulation or manufacturer	Otsuka Icu Medcl	13	Marketed
Dec 19, 1991	Aminosyn Ii 15% In Plastic ContainerNDA 20041 · New dosage form	Otsuka Icu Medcl	12	Marketed
Feb 5, 1993	Novamine 15% Sulfite Free In Plastic ContainerNDA 20107 · New formulation or manufacturer	Baxter Hlthcare	0	Discontinued
Apr 4, 1996	Aminosyn-Hf 8%ANDA 20345 · New formulation or manufacturer	Icu Medical Inc	4	Discontinued
Apr 4, 1996	Hepatasol 8%ANDA 20360 · New formulation or manufacturer	Baxter Hlthcare	6	Discontinued
Aug 30, 1996	Clinisol 15% Sulfite Free In Plastic ContainerANDA 20512 · New formulation or manufacturer	Baxter Hlthcare	6	Marketed
Aug 26, 1998	Prosol 20% Sulfite Free In Plastic ContainerNDA 20849 · New dosage form	Baxter Hlthcare	11	Marketed
Jun 19, 2003	Premasol 6% In Plastic Container, Premasol 10% In Plastic ContainerANDA 75880	Baxter Hlthcare	2	Marketed
Apr 13, 2012	Amino AcidsANDA 91112	B Braun	1	Marketed
—	Aminosyn-Hbc 7% In Plastic ContainerNDA 19400	Abbott	0	Discontinued
—	Aminosyn Ii 3.5% In Plastic ContainerNDA 19491	Abbott	0	Discontinued
—	Branchamin 4%NDA 18678	Baxter Hlthcare	1	Discontinued
—	Aminosyn 3.5% In Plastic Container, Aminosyn 3.5% M In Plastic ContainerNDA 18804	Abbott	0	Discontinued
—	Aminosyn 3.5% In Plastic Container, Aminosyn 3.5% M In Plastic ContainerNDA 18875	Abbott	0	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA