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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019826
Company: B BRAUN

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER THEOPHYLLINE 40MG/100ML INJECTABLE;INJECTION Discontinued None Yes No
THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER THEOPHYLLINE 80MG/100ML INJECTABLE;INJECTION Discontinued None Yes No
THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER THEOPHYLLINE 160MG/100ML INJECTABLE;INJECTION Discontinued None Yes No
THEOPHYLLINE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER THEOPHYLLINE 200MG/100ML INJECTABLE;INJECTION Discontinued None No No
THEOPHYLLINE 0.32% AND DEXTROSE 5% IN PLASTIC CONTAINER THEOPHYLLINE 320MG/100ML INJECTABLE;INJECTION Discontinued None Yes No
THEOPHYLLINE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER THEOPHYLLINE 400MG/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
08/14/1992 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
02/17/2012 SUPPL-23 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019826s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019826s023ltr.pdf
08/22/2014 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.
10/17/2008 SUPPL-21 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019826s021ltr.pdf
04/08/2008 SUPPL-20 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019826s020ltr.pdf
07/12/2002 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.
03/05/2002 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.
03/12/2001 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.
08/04/1998 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.
07/24/1996 SUPPL-7 Labeling

Label is not available on this site.
12/15/1994 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.
06/19/1995 SUPPL-2 Labeling

Label is not available on this site.
10/06/1993 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
02/17/2012 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019826s023lbl.pdf
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