Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020171
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% 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 | Yes | Yes |
| 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 | Yes | Yes |
| 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 | 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 |
|---|---|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|
| 01/26/2021 | SUPPL-80 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/018883Orig1s093, 020171Orig1s080ltr.pdf |
| 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-Container/Carton Labels, Labeling-Package Insert |
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 | Yes | 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 | Yes | 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 | Yes | AT | 020171 | FRESENIUS MEDCL |