Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017493
Company: BAXTER HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RENAMIN W/O ELECTROLYTES AMINO ACIDS 6.5% (6.5GM/100ML) INJECTABLE;INJECTION Discontinued None No No
TRAVASOL 10% W/O ELECTROLYTES AMINO ACIDS 10% (10GM/100ML) INJECTABLE;INJECTION Discontinued None No No
TRAVASOL 3.5% W/ ELECTROLYTES AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE 3.5%;51MG/100ML;131MG/100ML;218MG/100ML;35MG/100ML INJECTABLE;INJECTION Discontinued None No No
TRAVASOL 5.5% W/ ELECTROLYTES 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 5.5% W/O ELECTROLYTES AMINO ACIDS 5.5% (5.5GM/100ML) INJECTABLE;INJECTION Discontinued None No No
TRAVASOL 8.5% W/ ELECTROLYTES 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
TRAVASOL 8.5% W/O ELECTROLYTES AMINO ACIDS 8.5% (8.5GM/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
03/24/1976 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
01/17/2003 SUPPL-67 Manufacturing (CMC)-Control Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17493scs067ltr.pdf
04/30/2003 SUPPL-66 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17493slr066ltr.pdf
01/03/2003 SUPPL-65 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17493slr065ltr.pdf
03/31/1999 SUPPL-64 Manufacturing (CMC)-Control

Label is not available on this site.

04/05/1999 SUPPL-63 Manufacturing (CMC)-Control

Label is not available on this site.

02/18/1994 SUPPL-62 Manufacturing (CMC)-Control

Label is not available on this site.

05/19/1994 SUPPL-61 Manufacturing (CMC)

Label is not available on this site.

09/30/1994 SUPPL-60 Manufacturing (CMC)-Control

Label is not available on this site.

08/24/1992 SUPPL-59 Manufacturing (CMC)

Label is not available on this site.

04/03/1991 SUPPL-58 Manufacturing (CMC)-Control

Label is not available on this site.

09/14/1992 SUPPL-57 Manufacturing (CMC)-Control

Label is not available on this site.

03/12/1993 SUPPL-56 Labeling

Label is not available on this site.

03/26/1991 SUPPL-55 Manufacturing (CMC)-Control

Label is not available on this site.

05/04/1990 SUPPL-54 Manufacturing (CMC)-Control

Label is not available on this site.

03/12/1993 SUPPL-53 Labeling

Label is not available on this site.

04/30/1997 SUPPL-52 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/26/1989 SUPPL-51 Manufacturing (CMC)-Control

Label is not available on this site.

12/30/1987 SUPPL-49 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/18/1987 SUPPL-48 Labeling

Label is not available on this site.

07/25/1987 SUPPL-47 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/20/1985 SUPPL-46 Labeling

Label is not available on this site.

02/28/1984 SUPPL-45 Manufacturing (CMC)-Control

Label is not available on this site.

01/19/1983 SUPPL-43 Labeling

Label is not available on this site.

01/19/1983 SUPPL-42 Manufacturing (CMC)-Control

Label is not available on this site.

01/24/1985 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.

07/21/1982 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

03/08/1982 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

04/06/1982 SUPPL-37 Labeling

Label is not available on this site.

04/06/1982 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

02/16/1982 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

12/16/1981 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.

10/15/1982 SUPPL-33 Labeling

Label is not available on this site.

10/15/1982 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

06/29/1981 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

06/17/1981 SUPPL-29 Labeling

Label is not available on this site.

06/17/1981 SUPPL-28 Manufacturing (CMC)-Formulation

Label is not available on this site.

07/31/1980 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

06/03/1980 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

06/04/1979 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

04/27/1979 SUPPL-21 Labeling

Label is not available on this site.

11/28/1979 SUPPL-20 Labeling

Label is not available on this site.

11/28/1979 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

07/28/1978 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

07/28/1978 SUPPL-17 Labeling

Label is not available on this site.

08/29/1978 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

12/13/1977 SUPPL-15 Labeling

Label is not available on this site.

08/18/1977 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

07/12/1977 SUPPL-13 Labeling

Label is not available on this site.

07/12/1977 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

07/22/1977 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

05/10/1979 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

02/07/1977 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

04/01/1977 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

04/01/1977 SUPPL-7 Labeling

Label is not available on this site.

12/07/1977 SUPPL-6 Labeling

Label is not available on this site.

08/24/1976 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

06/28/1976 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

09/08/1976 SUPPL-3 Labeling

Label is not available on this site.

07/19/1976 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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