Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019894
Company: ICU MEDICAL INC

Products on NDA 019894

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DEXTROSE 50% IN PLASTIC CONTAINER	DEXTROSE	50GM/100ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019894

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/26/1989	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
12/18/2003	SUPPL-16	Labeling		Label is not available on this site.
11/01/2002	SUPPL-14	Manufacturing (CMC)-Packaging		Label is not available on this site.
07/16/1999	SUPPL-13	Labeling		Label is not available on this site.
05/19/1999	SUPPL-12	Labeling		Label is not available on this site.
01/05/1999	SUPPL-11	Labeling		Label is not available on this site.
08/22/1997	SUPPL-10	Labeling		Label is not available on this site.
08/18/1995	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
08/14/1995	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
08/27/1996	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
12/13/1993	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
01/21/1993	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
01/28/1992	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
09/10/1991	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
07/31/1990	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.