Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 020345
Company: ICU MEDICAL INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMINOSYN-HF 8% AMINO ACIDS 8% (8GM/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
04/04/1996 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
09/15/2005 SUPPL-8 Labeling

Label is not available on this site.

07/29/1997 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

04/01/1998 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

07/14/1997 SUPPL-1 Labeling

Label is not available on this site.

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