Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018429
Company: ICU MEDICAL INC
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 Prescription None No No
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.

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