Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018931
Company: BAXTER HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRAVASOL 10% IN PLASTIC CONTAINER AMINO ACIDS 10% (10MG/100ML) INJECTABLE;INJECTION Prescription None No No
TRAVASOL 5.5% IN PLASTIC CONTAINER AMINO ACIDS 5.5% (5.5GM/100ML) INJECTABLE;INJECTION Prescription None No No
TRAVASOL 8.5% IN PLASTIC CONTAINER AMINO ACIDS 8.5% (8.5GM/100ML) INJECTABLE;INJECTION Prescription 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
08/23/1984 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
01/15/2016 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

11/16/2017 SUPPL-49 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018931s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018931Orig1s049ltr.pdf
02/03/2015 SUPPL-48 Manufacturing (CMC)

Label is not available on this site.

09/15/2014 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

10/10/2003 SUPPL-35 Labeling

Label is not available on this site.

08/29/2001 SUPPL-33 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

04/21/2000 SUPPL-32 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

02/28/2001 SUPPL-31 Labeling

Label is not available on this site.

01/28/2000 SUPPL-30 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/30/1999 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

06/11/1999 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

04/29/1997 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

08/05/1994 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

02/18/1994 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

05/19/1994 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

09/30/1994 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

02/27/1992 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

02/27/1992 SUPPL-20 Labeling

Label is not available on this site.

08/24/1992 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

04/03/1991 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

09/14/1992 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

05/12/1993 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

12/11/1992 SUPPL-15 Labeling

Label is not available on this site.

03/26/1991 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

04/02/1993 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

04/02/1993 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

05/04/1990 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

02/15/1991 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

03/24/1993 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

07/26/1989 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

04/27/1988 SUPPL-7 Labeling

Label is not available on this site.

07/25/1987 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

11/12/1987 SUPPL-4 Labeling

Label is not available on this site.

04/26/1985 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

04/27/1989 SUPPL-2 Labeling

Label is not available on this site.

09/20/1985 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/16/2017 SUPPL-49 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018931s049lbl.pdf

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