Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020015
Company: ICU MEDICAL INC

Products on NDA 020015

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AMINOSYN II 10% IN PLASTIC CONTAINER	AMINO ACIDS	10% (10GM/100ML)	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020015

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/19/1991	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
09/15/2014	SUPPL-33	Manufacturing (CMC)		Label is not available on this site.
09/28/2011	SUPPL-28	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
05/13/2003	SUPPL-13	Labeling		Label is not available on this site.
06/30/2003	SUPPL-12	Labeling		Label is not available on this site.
11/01/2002	SUPPL-10	Manufacturing (CMC)-Packaging		Label is not available on this site.
05/05/1997	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
03/04/1997	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
08/14/1995	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
08/27/1996	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
07/11/1994	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
11/09/1995	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
04/05/1995	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
08/17/1992	SUPPL-1	Labeling		Label is not available on this site.