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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018807
Company: B BRAUN

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE 510MG/100ML;30GM/100ML;200MG/100ML;9.2GM/100ML;9.6GM/100ML SOLUTION;INTRAPERITONEAL Discontinued None No No
DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE 510MG/100ML;30GM/100ML;200MG/100ML;9.4GM/100ML;11GM/100ML SOLUTION;INTRAPERITONEAL Discontinued None No No
DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE 510MG/100ML;50GM/100ML;200MG/100ML;9.2GM/100ML;9.6GM/100ML SOLUTION;INTRAPERITONEAL Discontinued None No No
DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE 510MG/100ML;50GM/100ML;200MG/100ML;9.4GM/100ML;11GM/100ML SOLUTION;INTRAPERITONEAL 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
08/26/1983 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
04/05/2002 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.
02/09/1998 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.
10/26/1995 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.
09/13/1995 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.
09/11/1990 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.
04/12/1988 SUPPL-7 Labeling

Label is not available on this site.
04/19/1988 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.
10/10/1986 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.
08/27/1986 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.
03/05/1987 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.
04/03/1985 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.
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