Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020173
Company: BAXTER HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRAVASOL 5.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE 5.5%;102MG/100ML;522MG/100ML;431MG/100ML;224MG/100ML INJECTABLE;INJECTION Discontinued None No No
TRAVASOL 8.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE 8.5%;102MG/100ML;522MG/100ML;594MG/100ML;154MG/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
10/27/1995 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
10/29/2002 SUPPL-12 Labeling

Label is not available on this site.

08/29/2001 SUPPL-10 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

06/09/2000 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

04/21/2000 SUPPL-8 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

02/28/2001 SUPPL-7 Labeling

Label is not available on this site.

01/28/2000 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/30/1999 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

06/11/1999 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

12/18/1997 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

10/17/1997 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

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

Label is not available on this site.

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