Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020163
Company: BAXTER HLTHCARE
Company: BAXTER HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| 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 | AT | Yes | No |
| 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 | AT | Yes | No |
| 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 | AT | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 12/04/1992 | 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 |
|---|---|---|---|---|---|
| 06/05/2023 | SUPPL-30 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020163Orig1s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020163Orig1s030ltr.pdf | |
| 08/16/2016 | SUPPL-28 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017512s123,020163s028,020183s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017512Orig1s123,020163Orig1s028,020183Orig1s027ltr.pdf | |
| 09/01/2015 | SUPPL-27 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017512s122,020163s027,020183s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017512Orig1s122,020163Orig1s027,020183Orig1s026ltr.pdf | |
| 06/05/2015 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/09/2015 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020183s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017512Orig1s118,020163Orig1s025,020183Orig1s024ltr.pdf | |
| 09/30/2014 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/26/2013 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/19/2013 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017512s113,020163s020,020183s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017512Orig1s113,020163Orig1s020,020183Orig1s019ltr.pdf | |
| 08/09/2005 | SUPPL-13 | Manufacturing (CMC)-Packaging |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017512s104,106,020163s012,013,020183s011,012ltr.pdf |
| 08/09/2005 | SUPPL-12 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017512s104,106,020163s012,013,020183s011,012ltr.pdf |
| 02/12/2002 | SUPPL-8 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/22/2001 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/29/1997 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/22/1996 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/09/1995 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/01/1994 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/18/1994 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/30/1994 | 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 |
|---|---|---|---|---|---|
| 06/05/2023 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020163Orig1s030lbl.pdf | |
| 08/16/2016 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017512s123,020163s028,020183s027lbl.pdf | |
| 09/01/2015 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017512s122,020163s027,020183s026lbl.pdf | |
| 02/09/2015 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020183s024lbl.pdf | |
| 04/19/2013 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017512s113,020163s020,020183s019lbl.pdf |
DIANEAL PD-2 W/ DEXTROSE 1.5% 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 | 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 |
DIANEAL PD-2 W/ DEXTROSE 2.5% 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 | 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 |
DIANEAL PD-2 W/ DEXTROSE 4.25% 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 | 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 |