Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019438
Company: ICU MEDICAL INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMINOSYN II 10% AMINO ACIDS 10% (10GM/100ML) INJECTABLE;INJECTION Prescription None No No
AMINOSYN II 3.5% AMINO ACIDS 3.5% (3.5GM/100ML) INJECTABLE;INJECTION Discontinued None No No
AMINOSYN II 5% AMINO ACIDS 5% (5GM/100ML) INJECTABLE;INJECTION Discontinued None No No
AMINOSYN II 7% AMINO ACIDS 7% (7GM/100ML) INJECTABLE;INJECTION Prescription None No No
AMINOSYN II 8.5% AMINO ACIDS 8.5% (8.5GM/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
04/03/1986 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
10/25/2002 SUPPL-14 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
06/06/2003 SUPPL-13 Labeling

Label is not available on this site.

01/22/1999 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

05/05/1997 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

08/27/1996 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

07/11/1994 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

12/30/1993 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

09/28/1992 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

08/18/1992 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

12/30/1988 SUPPL-5 Labeling

Label is not available on this site.

02/10/1992 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

06/29/1987 SUPPL-3 Labeling

Label is not available on this site.

12/01/1987 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

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