An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 018429
Company: ICU MEDICAL INC

Products on NDA 018429

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AMINOSYN-RF 5.2%	AMINO ACIDS	5.2% (5.2GM/100ML)	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018429

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/28/1980	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
06/18/2003	SUPPL-21	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18429slr021ltr.pdf
10/25/2002	SUPPL-19	Manufacturing (CMC)	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17673scm066,17789scm052,etc,ltr.pdf
08/27/1996	SUPPL-18	Manufacturing (CMC)-Control		Label is not available on this site.
07/11/1994	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
08/18/1992	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
02/10/1992	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
08/19/1987	SUPPL-14	Labeling		Label is not available on this site.
01/31/1986	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
12/11/1985	SUPPL-10	Labeling		Label is not available on this site.
10/26/1985	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
05/08/1985	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
10/13/1983	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
07/05/1983	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
04/12/1983	SUPPL-4	Labeling		Label is not available on this site.
01/19/1982	SUPPL-3	Manufacturing (CMC)-Packaging		Label is not available on this site.
01/21/1983	SUPPL-2	Labeling		Label is not available on this site.
06/20/1981	SUPPL-1	Labeling		Label is not available on this site.

Top