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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018744
Company: B BRAUN

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
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
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
09/11/1990 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.
06/24/1985 SUPPL-7 Labeling

Label is not available on this site.
04/03/1985 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.
10/10/1985 SUPPL-5 Labeling

Label is not available on this site.
10/10/1985 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.
09/05/1985 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.
04/03/1985 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.
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