Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019893
Company: ICU MEDICAL INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEXTROSE 70% IN PLASTIC CONTAINER DEXTROSE 70GM/100ML INJECTABLE;INJECTION Prescription AP Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/26/1989 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
12/18/2003 SUPPL-16 Labeling

Label is not available on this site.

11/01/2002 SUPPL-14 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/16/1999 SUPPL-13 Labeling

Label is not available on this site.

05/19/1999 SUPPL-12 Labeling

Label is not available on this site.

01/05/1999 SUPPL-11 Labeling

Label is not available on this site.

08/22/1997 SUPPL-10 Labeling

Label is not available on this site.

08/18/1995 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

08/14/1995 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

08/27/1996 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

12/13/1993 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

01/21/1993 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

01/28/1992 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

09/10/1991 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

07/31/1990 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

DEXTROSE 70% IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 70GM/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEXTROSE 70% IN PLASTIC CONTAINER DEXTROSE 70GM/100ML INJECTABLE;INJECTION Prescription Yes AP 019626 B BRAUN
DEXTROSE 70% IN PLASTIC CONTAINER DEXTROSE 70GM/100ML INJECTABLE;INJECTION Prescription Yes AP 020047 BAXTER HLTHCARE
DEXTROSE 70% IN PLASTIC CONTAINER DEXTROSE 70GM/100ML INJECTABLE;INJECTION Prescription Yes AP 018561 ICU MEDICAL INC
DEXTROSE 70% IN PLASTIC CONTAINER DEXTROSE 70GM/100ML INJECTABLE;INJECTION Prescription Yes AP 019893 ICU MEDICAL INC

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