Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019634
Company: B BRAUN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEXTROSE 2.5% IN HALF-STRENGTH LACTATED RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 10MG/100ML;2.5GM/100ML;15MG/100ML;300MG/100ML;160MG/100ML INJECTABLE;INJECTION Prescription None No No
DEXTROSE 4% IN MODIFIED LACTATED RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 4MG/100ML;4GM/100ML;6MG/100ML;120MG/100ML;62MG/100ML INJECTABLE;INJECTION Discontinued None No No
DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/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
02/13/2013 SUPPL-33 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019634s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019634s033ltr.pdf
08/22/2014 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

09/27/2004 SUPPL-21 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19634s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19634s021ltr.pdf
07/23/2002 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

03/08/2002 SUPPL-18 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/12/2001 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

04/11/2000 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

05/04/1999 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

09/25/1998 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

04/26/1993 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

07/21/1993 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

12/29/1992 SUPPL-10 Manufacturing (CMC)

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.

03/25/1988 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
02/13/2013 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019634s033lbl.pdf
09/27/2004 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19634s021lbl.pdf

DEXTROSE 2.5% IN HALF-STRENGTH LACTATED RINGER'S IN PLASTIC CONTAINER

There are no Therapeutic Equivalents.

DEXTROSE 4% IN MODIFIED LACTATED RINGER'S IN PLASTIC CONTAINER

There are no Therapeutic Equivalents.

DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100ML INJECTABLE;INJECTION Prescription Yes AP 017608 ICU MEDICAL INC
DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100ML INJECTABLE;INJECTION Prescription No AP 019634 B BRAUN
LACTATED RINGER'S AND DEXTROSE 5% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100ML INJECTABLE;INJECTION Prescription No AP 016679 BAXTER HLTHCARE

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