FDA Approval Activities for this Drug
RenAmin (amino acid) Injection, Baxter Healthcare NDA 17-493/S-068 4/30/03
RenAmin (amino acid) Injection, Baxter Healthcare NDA 17-493/S-067 1/17/03 1/27/03
RenAmin (amino acid) Injection, Baxter Healthcare NDA 17-493/S-065 Travasol and Ren Amin (Amino Acid) Injections, Baxter Healthcare NDA 17-493 / S-067 1/17/03
Travasol - Sulfite Free (Amino Acid in Dextrose) Injection, Baxter NDA 19-520/SE8-018 4/12/00 4/13/00
Travasol Indications: Indicated as a caloric component in a parenteral nutrition regimen and as the protein source for offsetting nitrogen loss.
Travasol - Sulfite Free (Amino Acid with Electrolytes in Dextrose) Injection, Baxter Healthcare NDA 20-147/SE-006 4/12/00 4/13/00
Travasol Indications: Indicated as a caloric component in a parenteral nutrition regimen and as the protein source for offsetting nitrogen loss. ProcalAmine (3% amino acid and 3% glycerin/w electrolytes) Injection, B.Braun Medical Inc. TrophAmine (amino acid) Injection, B.Braun Medical Inc. HepatAmine (amino acid injections), B.Braun Medical Inc. | Novamine Amino Acid Injection, Hospira, Inc., Control Supplement | Aminosyn II (Amino Acid Injection), Hospira, Inc., Labeling Revision | Nephramine (Essential Amino Acid Injection), B. Braun Medical, Labeling Revision | Clinimix 2.75/10 Sulfite Free in Dextrose (amino acids and dextrose) Injection, Baxter Healthcare, Labeling Revision | Clinimix E 5/25 Sulfite Free with Elect in Dextrose (amino acids, calcium chloride, dextrose, magnesium chloride, potassium phosphate, dibasic, sodium acetate, and sodium chloride) Injection, Baxter Healthcare, Labeling Revision