Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 212347
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45% | POTASSIUM CHLORIDE; SODIUM CHLORIDE | 150MG/100ML;450MG/100ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
| POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% | POTASSIUM CHLORIDE; SODIUM CHLORIDE | 150MG/100ML;900MG/100ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
| POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9% | POTASSIUM CHLORIDE; SODIUM CHLORIDE | 300MG/100ML;900MG/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 |
|---|---|---|---|---|---|---|---|
| 09/17/2020 | ORIG-1 | Approval | STANDARD |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212347Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/212347Orig1s000ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/17/2020 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212347Orig1s000ltr.pdf |
POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45%
INJECTABLE;INJECTION; 150MG/100ML;450MG/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 0.45% | POTASSIUM CHLORIDE; SODIUM CHLORIDE | 150MG/100ML;450MG/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 017648 | BAXTER HLTHCARE |
| POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45% | POTASSIUM CHLORIDE; SODIUM CHLORIDE | 150MG/100ML;450MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 212347 | FRESENIUS KABI USA |
POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9%
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 0.3% AND SODIUM CHLORIDE 0.9%
INJECTABLE;INJECTION; 300MG/100ML;900MG/100ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9% | POTASSIUM CHLORIDE; SODIUM CHLORIDE | 300MG/100ML;900MG/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 017648 | BAXTER HLTHCARE |
| POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9% | POTASSIUM CHLORIDE; SODIUM CHLORIDE | 300MG/100ML;900MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 212347 | FRESENIUS KABI USA |