Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020171
Company: FRESENIUS MEDCL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML SOLUTION;INTRAPERITONEAL Prescription AT No No
DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 18.4MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML SOLUTION;INTRAPERITONEAL Prescription AT No No
DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 18.4MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML SOLUTION;INTRAPERITONEAL Prescription AT 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
08/19/1992 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
03/24/2016 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

01/08/2015 SUPPL-39 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018883Orig1s057,020171Orig1s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018883Orig1s057,020171Orig1s039ltr.pdf
04/23/2014 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

01/24/2014 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

01/13/2014 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

04/24/2014 SUPPL-33 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018883s051,020171s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018883Orig1s051,20171Orig1s033ltr.pdf
04/18/2013 SUPPL-30 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018883s048,020171s030lbl.pdf
02/22/2013 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

01/30/2013 SUPPL-26 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018883s044,020171s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018883Orig1s044,020171Orig1s026ltr.pdf
09/14/2009 SUPPL-15 Labeling-Package Insert, Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018883s033,020171s015ltr.pdf
05/06/2008 SUPPL-14 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

11/26/2003 SUPPL-10 Manufacturing (CMC)-Control Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18883scs028,20171scs010ltr.pdf
09/26/2001 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/18/1999 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/24/1997 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

06/14/1996 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

02/22/1996 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

01/19/1996 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

03/08/1996 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

03/10/1994 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/08/2015 SUPPL-39 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018883Orig1s057,020171Orig1s039lbl.pdf
04/24/2014 SUPPL-33 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018883s051,020171s033lbl.pdf
04/18/2013 SUPPL-30 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018883s048,020171s030lbl.pdf
01/30/2013 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018883s044,020171s026lbl.pdf

DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER

SOLUTION;INTRAPERITONEAL; 18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML SOLUTION;INTRAPERITONEAL Prescription No AT 020171 FRESENIUS MEDCL

DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER

SOLUTION;INTRAPERITONEAL; 18.4MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 18.4MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML SOLUTION;INTRAPERITONEAL Prescription No AT 020171 FRESENIUS MEDCL

DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER

SOLUTION;INTRAPERITONEAL; 18.4MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 18.4MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML SOLUTION;INTRAPERITONEAL Prescription No AT 020171 FRESENIUS MEDCL

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