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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 016822
Company: B BRAUN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FREAMINE 8.5% AMINO ACIDS 8.5% (8.5GM/100ML) INJECTABLE;INJECTION Discontinued None No No
FREAMINE HBC 6.9% AMINO ACIDS 6.9% (6.9GM/100ML) INJECTABLE;INJECTION Prescription None No No
FREAMINE II 8.5% AMINO ACIDS 8.5% (8.5GM/100ML) INJECTABLE;INJECTION Discontinued None No No
FREAMINE III 10% AMINO ACIDS 10% (10GM/100ML) INJECTABLE;INJECTION Prescription None No No
FREAMINE III 3% W/ ELECTROLYTES AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE 3%;54MG/100ML;40MG/100ML;150MG/100ML;200MG/100ML;120MG/100ML INJECTABLE;INJECTION Prescription None No No
FREAMINE III 8.5% AMINO ACIDS 8.5% (8.5GM/100ML) INJECTABLE;INJECTION Prescription None No No
FREAMINE III 8.5% W/ ELECTROLYTES AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM ACETATE; POTASSIUM CHLORIDE; SODIUM ACETATE 8.5%;110MG/100ML;230MG/100ML;10MG/100ML;440MG/100ML;690MG/100ML INJECTABLE;INJECTION Prescription None No No
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/27/2004 SUPPL-65 Manufacturing (CMC)-Control Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16822scs065_freamine_lbl.pdf
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