Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019520
Company: BAXTER HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRAVASOL 2.75% IN DEXTROSE 10% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE 2.75%;10GM/100ML INJECTABLE;INJECTION Discontinued None No No
TRAVASOL 2.75% IN DEXTROSE 15% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE 2.75%;15GM/100ML INJECTABLE;INJECTION Discontinued None No No
TRAVASOL 2.75% IN DEXTROSE 20% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE 2.75%;20GM/100ML INJECTABLE;INJECTION Discontinued None No No
TRAVASOL 2.75% IN DEXTROSE 25% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE 2.75%;25GM/100ML INJECTABLE;INJECTION Discontinued None No No
TRAVASOL 2.75% IN DEXTROSE 5% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE 2.75%;5GM/100ML INJECTABLE;INJECTION Discontinued None No No
TRAVASOL 4.25% IN DEXTROSE 10% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE 4.25%;10GM/100ML INJECTABLE;INJECTION Discontinued None No No
TRAVASOL 4.25% IN DEXTROSE 15% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE 4.25%;15GM/100ML INJECTABLE;INJECTION Discontinued None No No
TRAVASOL 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE 4.25%;20GM/100ML INJECTABLE;INJECTION Discontinued None No No
TRAVASOL 4.25% IN DEXTROSE 25% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE 4.25%;25GM/100ML INJECTABLE;INJECTION Discontinued None No No
TRAVASOL 4.25% IN DEXTROSE 5% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE 4.25%;5GM/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
09/23/1988 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-21 Manufacturing (CMC)

Label is not available on this site.

03/24/2000 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

11/24/1999 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

04/12/2000 SUPPL-18 Efficacy-Labeling Change With Clinical Data Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/19520S18LTR.PDF
03/31/1999 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

11/18/1997 SUPPL-16 Labeling

Label is not available on this site.

04/29/1997 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/18/1994 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

05/19/1994 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

09/30/1994 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

12/30/1991 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

02/27/1992 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

02/27/1992 SUPPL-8 Labeling

Label is not available on this site.

08/24/1992 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

09/14/1992 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

05/05/1993 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

03/26/1991 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

05/04/1990 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

02/15/1991 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

07/26/1989 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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