Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 018883
Company: FRESENIUS MEDCL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML SOLUTION;INTRAPERITONEAL Prescription AT No No
DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML SOLUTION;INTRAPERITONEAL Prescription AT No No
DELFLEX W/ DEXTROSE 2.5% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML SOLUTION;INTRAPERITONEAL Prescription AT No No
DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML SOLUTION;INTRAPERITONEAL Prescription AT No No
DELFLEX W/ DEXTROSE 4.25% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 25.7MG/100ML;4.25GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML SOLUTION;INTRAPERITONEAL Prescription AT No No
DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 25.7MG/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
11/30/1984 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
07/18/2016 SUPPL-61 Manufacturing (CMC)

Label is not available on this site.

12/28/2015 SUPPL-58 Manufacturing (CMC)

Label is not available on this site.

01/08/2015 SUPPL-57 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
12/08/2014 SUPPL-56 Manufacturing (CMC)

Label is not available on this site.

08/07/2014 SUPPL-55 Manufacturing (CMC)

Label is not available on this site.

04/23/2014 SUPPL-54 Manufacturing (CMC)

Label is not available on this site.

01/24/2014 SUPPL-53 Manufacturing (CMC)

Label is not available on this site.

01/13/2014 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

04/24/2014 SUPPL-51 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
07/26/2013 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

08/15/2013 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

04/18/2013 SUPPL-48 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018883s048,020171s030lbl.pdf
02/22/2013 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

01/30/2013 SUPPL-44 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-33 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-32 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

11/26/2003 SUPPL-28 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-26 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/18/1999 SUPPL-25 Manufacturing (CMC)-Packaging

Label is not available on this site.

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

Label is not available on this site.

06/14/1996 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

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

Label is not available on this site.

01/19/1996 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

07/07/1993 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

07/07/1993 SUPPL-19 Labeling

Label is not available on this site.

07/07/1993 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

07/11/1990 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

01/10/1989 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

02/05/1988 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

01/24/1990 SUPPL-12 Labeling

Label is not available on this site.

01/24/1990 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

01/24/1990 SUPPL-10 Labeling

Label is not available on this site.

01/24/1990 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

04/08/1987 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

01/14/1987 SUPPL-7 Labeling

Label is not available on this site.

07/21/1987 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

10/27/1987 SUPPL-5 Labeling

Label is not available on this site.

10/27/1987 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

06/16/1986 SUPPL-3 Labeling

Label is not available on this site.

06/16/1986 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

09/05/1985 SUPPL-1 Manufacturing (CMC)-Expiration Date

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-57 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018883Orig1s057,020171Orig1s039lbl.pdf
04/24/2014 SUPPL-51 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018883s051,020171s033lbl.pdf
04/18/2013 SUPPL-48 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-44 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018883s044,020171s026lbl.pdf

DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER

SOLUTION;INTRAPERITONEAL; 25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/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% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML SOLUTION;INTRAPERITONEAL Prescription No AT 018883 FRESENIUS MEDCL

DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM IN PLASTIC CONTAINER

SOLUTION;INTRAPERITONEAL; 25.7MG/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 IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML SOLUTION;INTRAPERITONEAL Prescription No AT 018883 FRESENIUS MEDCL
DIANEAL PD-2 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML SOLUTION;INTRAPERITONEAL Prescription Yes AT 017512 BAXTER HLTHCARE
DIANEAL PD-2 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML SOLUTION;INTRAPERITONEAL Prescription Yes AT 020163 BAXTER HLTHCARE

DELFLEX W/ DEXTROSE 2.5% IN PLASTIC CONTAINER

SOLUTION;INTRAPERITONEAL; 25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/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% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML SOLUTION;INTRAPERITONEAL Prescription No AT 018883 FRESENIUS MEDCL

DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM IN PLASTIC CONTAINER

SOLUTION;INTRAPERITONEAL; 25.7MG/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 IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML SOLUTION;INTRAPERITONEAL Prescription No AT 018883 FRESENIUS MEDCL
DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML SOLUTION;INTRAPERITONEAL Prescription Yes AT 017512 BAXTER HLTHCARE
DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML SOLUTION;INTRAPERITONEAL Prescription Yes AT 020163 BAXTER HLTHCARE

DELFLEX W/ DEXTROSE 4.25% IN PLASTIC CONTAINER

SOLUTION;INTRAPERITONEAL; 25.7MG/100ML;4.25GM/100ML;15.2MG/100ML;567MG/100ML;392MG/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% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 25.7MG/100ML;4.25GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML SOLUTION;INTRAPERITONEAL Prescription No AT 018883 FRESENIUS MEDCL

DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM IN PLASTIC CONTAINER

SOLUTION;INTRAPERITONEAL; 25.7MG/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 IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 25.7MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML SOLUTION;INTRAPERITONEAL Prescription No AT 018883 FRESENIUS MEDCL
DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 25.7MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML SOLUTION;INTRAPERITONEAL Prescription Yes AT 017512 BAXTER HLTHCARE
DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 25.7MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML SOLUTION;INTRAPERITONEAL Prescription Yes AT 020163 BAXTER HLTHCARE

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English