Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019691
Company: ICU MEDICAL INC
Company: ICU MEDICAL INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;74.5MG/100ML;900MG/100ML | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;149MG/100ML;900MG/100ML | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;224MG/100ML;900MG/100ML | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;149MG/100ML;900MG/100ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;298MG/100ML;900MG/100ML | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;224MG/100ML;900MG/100ML | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;298MG/100ML;900MG/100ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;74.5MG/100ML;900MG/100ML | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;149MG/100ML;900MG/100ML | INJECTABLE;INJECTION | Discontinued | None | 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 |
|---|---|---|---|---|---|---|---|
| 03/24/1988 | 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 |
|---|---|---|---|---|---|
| 09/08/2014 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/18/2002 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 12/01/1998 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/19/1999 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 06/11/1997 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/06/1996 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/04/1996 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/18/1995 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/14/1995 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/29/1996 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/27/1996 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/28/1992 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/10/1991 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/11/1990 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/22/1990 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
There are no Therapeutic Equivalents.
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
There are no Therapeutic Equivalents.
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
INJECTABLE;INJECTION; 5GM/100ML;149MG/100ML;900MG/100ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;149MG/100ML;900MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 213445 | FRESENIUS KABI USA |
| POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;149MG/100ML;900MG/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 019691 | ICU MEDICAL INC |
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
There are no Therapeutic Equivalents.
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
INJECTABLE;INJECTION; 5GM/100ML;298MG/100ML;900MG/100ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;298MG/100ML;900MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 213445 | FRESENIUS KABI USA |
| POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;298MG/100ML;900MG/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 019691 | ICU MEDICAL INC |
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
There are no Therapeutic Equivalents.