Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019121
Company: B BRAUN

Products on NDA 019121

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER	BRETYLIUM TOSYLATE	100MG/100ML	INJECTABLE;INJECTION	Discontinued	None	No	No
BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER	BRETYLIUM TOSYLATE	200MG/100ML	INJECTABLE;INJECTION	Discontinued	None	No	No
BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER	BRETYLIUM TOSYLATE	400MG/100ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019121

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/29/1986	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
10/06/1993	SUPPL-3	Labeling		Label is not available on this site.
07/13/1990	SUPPL-2	Manufacturing (CMC)-Formulation		Label is not available on this site.