Drugs@FDA: FDA Approved Drug Products

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

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