Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019222
Company: ICU MEDICAL INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE 50MG/ML INJECTABLE;INJECTION Discontinued None Yes 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
07/13/1984 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
01/22/1999 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

09/17/1998 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/22/1997 SUPPL-5 Labeling

Label is not available on this site.

08/18/1995 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

03/25/1994 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

08/11/1986 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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