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Drugs@FDA: FDA-Approved Drugs

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

Products on NDA 019826

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019826

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.

Labels for NDA 019826

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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