Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019631
Company: B BRAUN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 10GM/100ML;110MG/100ML INJECTABLE;INJECTION Prescription None No No
DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 10GM/100ML;200MG/100ML INJECTABLE;INJECTION Prescription None No No
DEXTROSE 10% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 10GM/100ML;330MG/100ML INJECTABLE;INJECTION Prescription None No No
DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 10GM/100ML;450MG/100ML INJECTABLE;INJECTION Prescription None No No
DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 10GM/100ML;900MG/100ML INJECTABLE;INJECTION Prescription None No No
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 2.5GM/100ML;110MG/100ML INJECTABLE;INJECTION Prescription None No No
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 2.5GM/100ML;200MG/100ML INJECTABLE;INJECTION Prescription None No No
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 2.5GM/100ML;330MG/100ML INJECTABLE;INJECTION Prescription None No No
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 2.5GM/100ML;450MG/100ML INJECTABLE;INJECTION Prescription AP No No
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 2.5GM/100ML;900MG/100ML INJECTABLE;INJECTION Prescription None No No
DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 3.3GM/100ML;300MG/100ML INJECTABLE;INJECTION Prescription None No No
DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 5GM/100ML;110MG/100ML INJECTABLE;INJECTION Prescription None No No
DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 5GM/100ML;200MG/100ML INJECTABLE;INJECTION Prescription AP No No
DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 5GM/100ML;330MG/100ML INJECTABLE;INJECTION Prescription AP No No
DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 5GM/100ML;450MG/100ML INJECTABLE;INJECTION Prescription AP No No
DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 5GM/100ML;900MG/100ML INJECTABLE;INJECTION Prescription AP No 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
02/24/1988 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
01/24/2014 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

08/22/2014 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

09/27/2004 SUPPL-23 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19631s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19631s023ltr.pdf
07/23/2002 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

03/08/2002 SUPPL-20 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/12/2001 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

04/11/2000 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

09/25/1998 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

03/17/1995 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

12/19/1994 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

07/21/1993 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

12/29/1992 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

08/29/1991 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

09/18/1990 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

01/19/1990 SUPPL-9 Labeling

Label is not available on this site.

04/13/1990 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/26/1989 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

01/19/1990 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

05/05/1989 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

11/21/1989 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

12/21/1988 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

08/25/1988 SUPPL-2 Manufacturing (CMC)-Formulation

Label is not available on this site.

03/25/1988 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
09/27/2004 SUPPL-23 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19631s023lbl.pdf

DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER

There are no Therapeutic Equivalents.

DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER

There are no Therapeutic Equivalents.

DEXTROSE 10% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER

There are no Therapeutic Equivalents.

DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

There are no Therapeutic Equivalents.

DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

There are no Therapeutic Equivalents.

DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER

There are no Therapeutic Equivalents.

DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER

There are no Therapeutic Equivalents.

DEXTROSE 2.5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER

There are no Therapeutic Equivalents.

DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 2.5GM/100ML;450MG/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 2.5GM/100ML;450MG/100ML INJECTABLE;INJECTION Prescription No AP 019631 B BRAUN
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 2.5GM/100ML;450MG/100ML INJECTABLE;INJECTION Prescription Yes AP 016697 BAXTER HLTHCARE

DEXTROSE 2.5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

There are no Therapeutic Equivalents.

DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER

There are no Therapeutic Equivalents.

DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER

There are no Therapeutic Equivalents.

DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 5GM/100ML;200MG/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 5GM/100ML;200MG/100ML INJECTABLE;INJECTION Prescription No AP 019631 B BRAUN
DEXTROSE 5% IN SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 5GM/100ML;200MG/100ML INJECTABLE;INJECTION Prescription No AP 016689 BAXTER HLTHCARE

DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 5GM/100ML;330MG/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 5GM/100ML;330MG/100ML INJECTABLE;INJECTION Prescription No AP 019631 B BRAUN
DEXTROSE 5% IN SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 5GM/100ML;330MG/100ML INJECTABLE;INJECTION Prescription No AP 016687 BAXTER HLTHCARE

DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 5GM/100ML;450MG/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 5GM/100ML;450MG/100ML INJECTABLE;INJECTION Prescription No AP 019631 B BRAUN
DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 5GM/100ML;450MG/100ML INJECTABLE;INJECTION Prescription Yes AP 017607 ICU MEDICAL INC
DEXTROSE 5% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 5GM/100ML;450MG/100ML INJECTABLE;INJECTION Prescription No AP 016683 BAXTER HLTHCARE

DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 5GM/100ML;900MG/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 5GM/100ML;900MG/100ML INJECTABLE;INJECTION Prescription No AP 019631 B BRAUN
DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 5GM/100ML;900MG/100ML INJECTABLE;INJECTION Prescription Yes AP 017585 ICU MEDICAL INC
DEXTROSE 5% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 5GM/100ML;900MG/100ML INJECTABLE;INJECTION Prescription No AP 016678 BAXTER HLTHCARE

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