Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020147
Company: BAXTER HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRAVASOL 2.75% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 10% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE 2.75%;10GM/100ML;51MG/100ML;261MG/100ML;216MG/100ML;112MG/100ML INJECTABLE;INJECTION Discontinued None No No
TRAVASOL 2.75% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 15% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE 2.75%;15GM/100ML;51MG/100ML;261MG/100ML;216MG/100ML;112MG/100ML INJECTABLE;INJECTION Discontinued None No No
TRAVASOL 2.75% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 20% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE 2.75%;20GM/100ML;51MG/100ML;261MG/100ML;216MG/100ML;112MG/100ML INJECTABLE;INJECTION Discontinued None No No
TRAVASOL 2.75% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE 2.75%;25GM/100ML;51MG/100ML;261MG/100ML;216MG/100ML;112MG/100ML INJECTABLE;INJECTION Discontinued None No No
TRAVASOL 2.75% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 5% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE 2.75%;5GM/100ML;51MG/100ML;261MG/100ML;216MG/100ML;112MG/100ML INJECTABLE;INJECTION Discontinued None No No
TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 10% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE 4.25%;10GM/100ML;51MG/100ML;261MG/100ML;297MG/100ML;77MG/100ML INJECTABLE;INJECTION Discontinued None No No
TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 15% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE 4.25%;15GM/100ML;51MG/100ML;261MG/100ML;297MG/100ML;77MG/100ML INJECTABLE;INJECTION Discontinued None No No
TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 20% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE 4.25%;20GM/100ML;51MG/100ML;261MG/100ML;297MG/100ML;77MG/100ML INJECTABLE;INJECTION Discontinued None No No
TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE 4.25%;25GM/100ML;51MG/100ML;261MG/100ML;297MG/100ML;77MG/100ML INJECTABLE;INJECTION Discontinued None No No
TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 5% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE 4.25%;5GM/100ML;51MG/100ML;261MG/100ML;297MG/100ML;77MG/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
10/23/1995 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
08/14/2001 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

03/24/2000 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

11/24/1999 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

04/12/2000 SUPPL-6 Efficacy-Labeling Change With Clinical Data Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20147S06LTR.PDF
03/31/1999 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

11/06/1997 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

10/09/1997 SUPPL-2 Labeling

Label is not available on this site.

04/29/1997 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

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