Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019492
Company: ICU MEDICAL INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMINOSYN-PF 10% 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
10/17/1986 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
10/25/2002 SUPPL-16 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
09/11/2002 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

06/08/1999 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

05/05/1997 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

08/27/1996 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

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

Label is not available on this site.

12/30/1993 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

09/28/1992 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

12/21/1990 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

08/18/1992 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

02/10/1992 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

10/20/1987 SUPPL-4 Labeling

Label is not available on this site.

12/01/1987 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

11/24/1987 SUPPL-2 Labeling

Label is not available on this site.

11/24/1987 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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