Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 018563
Company: ICU MEDICAL INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEXTROSE 50% IN PLASTIC CONTAINER DEXTROSE 50GM/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
03/23/1982 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
05/14/2018 SUPPL-60 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018561s060,018562s059,018563s060,018564s062,019345s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018564Orig1s062,019345Orig1s047,018562Orig1s059,018563Orig1s060,018561Orig1s060ltr.pdf
02/22/2016 SUPPL-57 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018561s057,018562s056,018563s057,018564s059,019345s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018564Orig1s059,019345Orig1s044,018562Org1s056,018563Orig1s057,018561Orig1s057ltr.pdf
09/11/2003 SUPPL-43 Labeling

Label is not available on this site.

11/01/2002 SUPPL-41 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/16/1999 SUPPL-40 Labeling

Label is not available on this site.

05/27/1999 SUPPL-38 Labeling

Label is not available on this site.

12/01/1998 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

06/11/1997 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

08/20/1997 SUPPL-35 Labeling

Label is not available on this site.

03/28/1997 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

08/06/1996 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

03/04/1996 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

08/18/1995 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

08/27/1996 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

12/13/1993 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

01/21/1993 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

01/28/1992 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

09/10/1991 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

01/11/1990 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

02/22/1990 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

11/26/1986 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

08/08/1986 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

01/31/1986 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

09/08/1984 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

10/22/1984 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

03/11/1985 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

09/26/1985 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

10/29/1985 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

11/28/1984 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

08/31/1988 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

01/17/1984 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

10/17/1984 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

03/21/1984 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

06/25/1986 SUPPL-5 Labeling

Label is not available on this site.

06/25/1986 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

02/17/1984 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

07/26/1982 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

03/01/1984 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/14/2018 SUPPL-60 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018561s060,018562s059,018563s060,018564s062,019345s047lbl.pdf
02/22/2016 SUPPL-57 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018561s057,018562s056,018563s057,018564s059,019345s044lbl.pdf

DEXTROSE 50% IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 50GM/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEXTROSE 50% IN PLASTIC CONTAINER DEXTROSE 50GM/100ML INJECTABLE;INJECTION Prescription Yes AP 020047 BAXTER HLTHCARE
DEXTROSE 50% IN PLASTIC CONTAINER DEXTROSE 50GM/100ML INJECTABLE;INJECTION Prescription Yes AP 018563 ICU MEDICAL INC

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English