Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020047
Company: BAXTER HLTHCARE
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
DEXTROSE 60% IN PLASTIC CONTAINER DEXTROSE 60GM/100ML INJECTABLE;INJECTION Discontinued None No No
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
07/02/1991 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
11/10/2015 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

02/03/2015 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

08/05/2019 SUPPL-21 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020047s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/016673Orig1s149, 016694Orig1s121, 020047Orig1s021, 020179Orig1s012ltr.pdf
12/22/2014 SUPPL-20 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017521s068lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016673Orig1s147,016694Orig1s119,017521Orig1s068,020047Orig1s020ltr.pdf
07/31/2003 SUPPL-17 Labeling

Label is not available on this site.

08/29/2001 SUPPL-15 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

08/31/2001 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

08/31/2001 SUPPL-13 Labeling

Label is not available on this site.

02/28/2001 SUPPL-12 Labeling

Label is not available on this site.

10/25/2000 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/24/1999 SUPPL-10 Labeling

Label is not available on this site.

01/28/2000 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/30/1999 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

04/29/1997 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

07/29/1996 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

07/29/1996 SUPPL-5 Labeling

Label is not available on this site.

02/18/1994 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

09/30/1994 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

12/11/1991 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

06/01/1993 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
08/05/2019 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020047s021lbl.pdf
12/22/2014 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017521s068lbl.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

DEXTROSE 60% IN PLASTIC CONTAINER

There are no Therapeutic Equivalents.

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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