Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019626
Company: B BRAUN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEXTROSE 10% IN PLASTIC CONTAINER DEXTROSE 10GM/100ML INJECTABLE;INJECTION Prescription AP Yes Yes
DEXTROSE 2.5% IN PLASTIC CONTAINER DEXTROSE 2.5GM/100ML INJECTABLE;INJECTION Discontinued None No No
DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE 5GM/100ML INJECTABLE;INJECTION Prescription AP Yes Yes
DEXTROSE 7.7% IN PLASTIC CONTAINER DEXTROSE 7.7GM/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
02/02/1988 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
11/20/2015 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

02/18/2015 SUPPL-30 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019626s030lbl.pdf
08/22/2014 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

02/13/2004 SUPPL-19 Manufacturing (CMC)-Control Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19626scs019_dextrose_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19626scs019ltr.pdf
07/23/2002 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

03/08/2002 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/12/2001 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

04/11/2000 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

09/25/1998 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

06/01/1993 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

04/26/1993 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

07/21/1993 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

08/29/1991 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

09/18/1990 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

04/13/1990 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/26/1989 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

05/05/1989 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

11/21/1989 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

12/21/1988 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

03/16/1988 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/18/2015 SUPPL-30 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019626s030lbl.pdf
02/13/2004 SUPPL-19 Manufacturing (CMC)-Control Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19626scs019_dextrose_lbl.pdf

DEXTROSE 10% IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 10GM/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEXTROSE 10% IN PLASTIC CONTAINER DEXTROSE 10GM/100ML INJECTABLE;INJECTION Prescription Yes AP 019626 B BRAUN
DEXTROSE 10% IN PLASTIC CONTAINER DEXTROSE 10GM/100ML INJECTABLE;INJECTION Prescription Yes AP 016694 BAXTER HLTHCARE
DEXTROSE 10% IN PLASTIC CONTAINER DEXTROSE 10GM/100ML INJECTABLE;INJECTION Prescription No AP 209448 FRESENIUS KABI USA
DEXTROSE 10% IN PLASTIC CONTAINER DEXTROSE 10GM/100ML INJECTABLE;INJECTION Prescription Yes AP 018080 ICU MEDICAL INC

DEXTROSE 2.5% IN PLASTIC CONTAINER

There are no Therapeutic Equivalents.

DEXTROSE 5% IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 5GM/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE 5GM/100ML INJECTABLE;INJECTION Prescription Yes AP 016730 B BRAUN
DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE 5GM/100ML INJECTABLE;INJECTION Prescription Yes AP 019626 B BRAUN
DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE 5GM/100ML INJECTABLE;INJECTION Prescription Yes AP 016673 BAXTER HLTHCARE
DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE 5GM/100ML INJECTABLE;INJECTION Prescription Yes AP 020179 BAXTER HLTHCARE
DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE 5GM/100ML INJECTABLE;INJECTION Prescription Yes AP 019466 HOSPIRA
DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE 5GM/100ML INJECTABLE;INJECTION Prescription Yes AP 019479 HOSPIRA

DEXTROSE 7.7% 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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