Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020041
Company: ICU MEDICAL INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMINOSYN II 15% IN PLASTIC CONTAINER AMINO ACIDS 15% (15GM/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 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
04/27/2007 SUPPL-20 Labeling-Container/Carton Labels

Label is not available on this site.

01/27/2003 SUPPL-13 Manufacturing (CMC)-Control Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20041scs013ltr.pdf
11/08/2002 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

08/21/2002 SUPPL-11 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20041slr011ltr.pdf
05/05/1997 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

08/06/1996 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

03/04/1997 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

08/14/1995 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

08/27/1996 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

07/11/1994 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

04/05/1995 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/17/1992 SUPPL-1 Labeling

Label is not available on this site.

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