Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019564
Company: ABBOTT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE 3.5%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100ML INJECTABLE;INJECTION Discontinued None No No
AMINOSYN II 3.5% W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE 3.5%;25GM/100ML;51MG/100ML;22.4MG/100ML;261MG/100ML;205MG/100ML INJECTABLE;INJECTION Discontinued None No No
AMINOSYN II 4.25% M IN DEXTROSE 10% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE 4.25%;10GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100ML INJECTABLE;INJECTION Discontinued None No No
AMINOSYN II 4.25% W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE 4.25%;25GM/100ML;51MG/100ML;22.4MG/100ML;261MG/100ML;205MG/100ML INJECTABLE;INJECTION Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/16/1986 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/28/1987 SUPPL-3 Labeling

Label is not available on this site.

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