Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019708
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 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | POTASSIUM CHLORIDE; SODIUM CHLORIDE | 37MG/100ML;900MG/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| POTASSIUM CHLORIDE 0.075% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | POTASSIUM CHLORIDE; SODIUM CHLORIDE | 75MG/100ML;900MG/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| POTASSIUM CHLORIDE 0.11% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | POTASSIUM CHLORIDE; SODIUM CHLORIDE | 110MG/100ML;900MG/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | POTASSIUM CHLORIDE; SODIUM CHLORIDE | 150MG/100ML;900MG/100ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
| POTASSIUM CHLORIDE 0.22% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | POTASSIUM CHLORIDE; SODIUM CHLORIDE | 220MG/100ML;900MG/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| POTASSIUM CHLORIDE 0.3% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | POTASSIUM CHLORIDE; SODIUM CHLORIDE | 300MG/100ML;900MG/100ML | INJECTABLE;INJECTION | Discontinued | None | 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 |
|---|---|---|---|---|---|
| 08/22/2014 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/31/2005 | SUPPL-16 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019630s026,019708s016ltr.pdf |
| 09/27/2004 | SUPPL-13 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19708s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19708s013ltr.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. |
||
| 05/04/1999 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/25/1998 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/21/1993 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/29/1992 | SUPPL-5 | Manufacturing (CMC) |
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 |
|---|---|---|---|---|---|
| 09/27/2004 | SUPPL-13 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19708s013lbl.pdf |
POTASSIUM CHLORIDE 0.037% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
There are no Therapeutic Equivalents.
POTASSIUM CHLORIDE 0.075% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
There are no Therapeutic Equivalents.
POTASSIUM CHLORIDE 0.11% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
There are no Therapeutic Equivalents.
POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
INJECTABLE;INJECTION; 150MG/100ML;900MG/100ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% | POTASSIUM CHLORIDE; SODIUM CHLORIDE | 150MG/100ML;900MG/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 017648 | BAXTER HLTHCARE |
| POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% | POTASSIUM CHLORIDE; SODIUM CHLORIDE | 150MG/100ML;900MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 212347 | FRESENIUS KABI USA |
| POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | POTASSIUM CHLORIDE; SODIUM CHLORIDE | 150MG/100ML;900MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 019708 | B BRAUN |
POTASSIUM CHLORIDE 0.22% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
There are no Therapeutic Equivalents.
POTASSIUM CHLORIDE 0.3% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
There are no Therapeutic Equivalents.