Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019008
Company: HOSPIRA INC

Products on NDA 019008

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER	BRETYLIUM TOSYLATE	800MG/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 019008

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/16/1986	ORIG-1	Approval	Type 3 - New Dosage Form	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
06/29/2001	SUPPL-21	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
11/05/1998	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
04/16/1999	SUPPL-19	Labeling		Label is not available on this site.
06/12/1997	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
03/18/1997	SUPPL-17	Manufacturing (CMC)-Control		Label is not available on this site.
02/02/1996	SUPPL-16	Manufacturing (CMC)-Packaging		Label is not available on this site.
08/03/1995	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
06/26/1996	SUPPL-14	Manufacturing (CMC)-Control		Label is not available on this site.
03/04/1994	SUPPL-12	Labeling		Label is not available on this site.
07/18/1991	SUPPL-11	Manufacturing (CMC)-Packaging		Label is not available on this site.
12/31/1991	SUPPL-10	Manufacturing (CMC)-Packaging		Label is not available on this site.
03/20/1990	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
03/23/1990	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
11/22/1988	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
09/16/1987	SUPPL-6	Manufacturing (CMC)-Packaging		Label is not available on this site.
08/26/1987	SUPPL-5	Manufacturing (CMC)-Packaging		Label is not available on this site.
10/29/1986	SUPPL-4	Manufacturing (CMC)-Formulation		Label is not available on this site.
03/13/1987	SUPPL-3	Manufacturing (CMC)-Formulation		Label is not available on this site.
08/08/1986	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
09/24/1986	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.