Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018883
Company: FRESENIUS MEDCL
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 | Yes | Yes |
| 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 | Yes | Yes |
| 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 | Yes | Yes |
| 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 | Yes | Yes |
| 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 | Yes | Yes |
| 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 | 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 |
|---|---|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|
| 01/26/2021 | SUPPL-93 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/018883Orig1s093, 020171Orig1s080ltr.pdf |
| 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 | Yes | 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 | Yes | 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 | VANTIVE US 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 | VANTIVE US 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 | Yes | 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 | Yes | 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 | VANTIVE US 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 | VANTIVE US 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 | Yes | 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 | Yes | 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 | VANTIVE US 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 | VANTIVE US HLTHCARE |