Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019211
Company: HOSPIRA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER THEOPHYLLINE 40MG/100ML INJECTABLE;INJECTION Discontinued None Yes No
THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER THEOPHYLLINE 80MG/100ML INJECTABLE;INJECTION Discontinued None No No
THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER THEOPHYLLINE 160MG/100ML INJECTABLE;INJECTION Discontinued None Yes No
THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER THEOPHYLLINE 200MG/100ML INJECTABLE;INJECTION Discontinued None No No
THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER THEOPHYLLINE 400MG/100ML INJECTABLE;INJECTION Discontinued None No No
THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER THEOPHYLLINE 320MG/100ML INJECTABLE;INJECTION Discontinued None Yes No
THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER THEOPHYLLINE 4MG/ML INJECTABLE;INJECTION Discontinued None Yes 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
12/14/1984 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
03/26/2009 SUPPL-42 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019211s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019211s042ltr.pdf
10/31/2008 SUPPL-40 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019211s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019211s040ltr.pdf
11/01/2002 SUPPL-30 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/10/1998 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

07/10/1997 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

07/22/1996 SUPPL-26 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/05/1996 SUPPL-25 Labeling

Label is not available on this site.

02/13/1996 SUPPL-24 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/21/1995 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

07/09/1996 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

07/09/1996 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

02/02/1996 SUPPL-18 Labeling

Label is not available on this site.

07/13/1992 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/02/1991 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/23/1992 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

02/22/1990 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

01/20/1988 SUPPL-11 Labeling

Label is not available on this site.

01/20/1988 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

10/31/1986 SUPPL-8 Labeling

Label is not available on this site.

03/23/1992 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

11/26/1986 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

08/11/1986 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

08/08/1986 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

01/24/1986 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

08/29/1986 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

01/31/1986 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/26/2009 SUPPL-42 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019211s042lbl.pdf
10/31/2008 SUPPL-40 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019211s040lbl.pdf

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