Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020147
Company: BAXTER HLTHCARE

Products on NDA 020147

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020147

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.