Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 020041
Company: ICU MEDICAL INC

Products on NDA 020041

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AMINOSYN II 15% IN PLASTIC CONTAINER	AMINO ACIDS	15% (15GM/100ML)	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020041

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 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
04/27/2007	SUPPL-20	Labeling-Container/Carton Labels		Label is not available on this site.
01/27/2003	SUPPL-13	Manufacturing (CMC)-Control	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20041scs013ltr.pdf
11/08/2002	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
08/21/2002	SUPPL-11	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20041slr011ltr.pdf
05/05/1997	SUPPL-10	Manufacturing (CMC)-Control		Label is not available on this site.
08/06/1996	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
03/04/1997	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
08/14/1995	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
08/27/1996	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
07/11/1994	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
04/05/1995	SUPPL-2	Manufacturing (CMC)-Packaging		Label is not available on this site.
08/17/1992	SUPPL-1	Labeling		Label is not available on this site.