Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019699
Company: B BRAUN
Company: B BRAUN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE | 5GM/100ML;37MG/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE | 5GM/100ML;75MG/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE | 5GM/100ML;110MG/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE | 5GM/100ML;150MG/100ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
| POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE | 5GM/100ML;220MG/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE | 5GM/100ML;300MG/100ML | INJECTABLE;INJECTION | Prescription | AP | 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 |
|---|---|---|---|---|---|---|---|
| 09/29/1989 | 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 |
|---|---|---|---|---|---|
| 07/10/2020 | SUPPL-33 | Labeling-Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019699s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/019699Orig1s033ltr.pdf | |
| 08/22/2014 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/27/2004 | SUPPL-13 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19699s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19699s013ltr.pdf | |
| 07/23/2002 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/08/2002 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/12/2001 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/11/2000 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/04/1999 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/25/1998 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/21/1993 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/29/1991 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/21/1990 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/18/1990 | 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 |
|---|---|---|---|---|---|
| 07/10/2020 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019699s033lbl.pdf | |
| 07/10/2020 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019699s033lbl.pdf | |
| 09/27/2004 | SUPPL-13 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19699s013lbl.pdf |
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% IN PLASTIC CONTAINER
There are no Therapeutic Equivalents.
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% IN PLASTIC CONTAINER
There are no Therapeutic Equivalents.
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% IN PLASTIC CONTAINER
There are no Therapeutic Equivalents.
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% IN PLASTIC CONTAINER
INJECTABLE;INJECTION; 5GM/100ML;150MG/100ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% | DEXTROSE; POTASSIUM CHLORIDE | 5GM/100ML;150MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 212346 | FRESENIUS KABI USA |
| DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE | 5GM/100ML;150MG/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 017634 | BAXTER HLTHCARE |
| POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE | 5GM/100ML;150MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 019699 | B BRAUN |
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% IN PLASTIC CONTAINER
There are no Therapeutic Equivalents.
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER
INJECTABLE;INJECTION; 5GM/100ML;300MG/100ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEXTROSE 5% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE | 5GM/100ML;300MG/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 017634 | BAXTER HLTHCARE |
| POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE | 5GM/100ML;300MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 019699 | B BRAUN |