Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018744
Company: B BRAUN
Company: B BRAUN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
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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 0.15% IN DEXTROSE 5% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE | 5GM/100ML;150MG/100ML | INJECTABLE;INJECTION | Discontinued | None | 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 | 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 |
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11/09/1982 | 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 |
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09/11/1990 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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06/24/1985 | SUPPL-7 | Labeling |
Label is not available on this site. |
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04/03/1985 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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10/10/1985 | SUPPL-5 | Labeling |
Label is not available on this site. |
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10/10/1985 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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09/05/1985 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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04/03/1985 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |