Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019398
Company: ICU MEDICAL INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMINOSYN-PF 7% AMINO ACIDS 7% (7GM/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
09/06/1985 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
05/24/2016 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

01/19/2016 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

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.

08/18/1992 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

02/10/1992 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

08/17/1987 SUPPL-6 Labeling

Label is not available on this site.

12/15/1986 SUPPL-5 Labeling

Label is not available on this site.

12/15/1986 SUPPL-4 Manufacturing (CMC)-Formulation

Label is not available on this site.

01/31/1986 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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