Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018649
Company: BAXTER HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
THEOPHYLLINE AND DEXTROSE 5% IN PLASTIC CONTAINER THEOPHYLLINE 40MG/100ML INJECTABLE;INJECTION Discontinued None No No
THEOPHYLLINE AND DEXTROSE 5% IN PLASTIC CONTAINER THEOPHYLLINE 80MG/100ML INJECTABLE;INJECTION Discontinued None No No
THEOPHYLLINE AND DEXTROSE 5% IN PLASTIC CONTAINER THEOPHYLLINE 160MG/100ML INJECTABLE;INJECTION Discontinued None No No
THEOPHYLLINE AND DEXTROSE 5% IN PLASTIC CONTAINER THEOPHYLLINE 200MG/100ML INJECTABLE;INJECTION Discontinued None No No
THEOPHYLLINE AND DEXTROSE 5% IN PLASTIC CONTAINER THEOPHYLLINE 400MG/100ML INJECTABLE;INJECTION Discontinued None No No
THEOPHYLLINE AND DEXTROSE 5% IN PLASTIC CONTAINER THEOPHYLLINE 320MG/100ML INJECTABLE;INJECTION Discontinued None No No
THEOPHYLLINE AND DEXTROSE 5% IN PLASTIC CONTAINER THEOPHYLLINE 4MG/ML 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
07/26/1982 ORIG-1 Approval Type 4 - New Combination 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
10/17/2008 SUPPL-43 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018649s043ltr.pdf
12/31/2003 SUPPL-40 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18649slr040_viaflex_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18649slr040ltr.pdf
11/23/1999 SUPPL-38 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/16/1999 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

12/22/1997 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

05/02/1997 SUPPL-35 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/04/1996 SUPPL-34 Labeling

Label is not available on this site.

07/27/1994 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

02/25/1994 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

09/26/1994 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

05/27/1993 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

08/30/1991 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

11/03/1992 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

10/16/1992 SUPPL-26 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/26/1989 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

01/12/1989 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

11/18/1987 SUPPL-22 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/25/1987 SUPPL-21 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/28/1987 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

02/27/1986 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/26/1985 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

09/14/1985 SUPPL-13 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

04/10/1985 SUPPL-11 Labeling

Label is not available on this site.

11/13/1985 SUPPL-10 Labeling

Label is not available on this site.

11/13/1985 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

06/13/1985 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

04/30/1984 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

10/04/1984 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

04/15/1986 SUPPL-5 Labeling

Label is not available on this site.

02/28/1984 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

04/30/1984 SUPPL-3 Labeling

Label is not available on this site.

09/02/1982 SUPPL-1 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/31/2003 SUPPL-40 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18649slr040_viaflex_lbl.pdf

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