Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018460
Company: B BRAUN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 26MG/100ML;1.5GM/100ML;15MG/100ML;560MG/100ML;390MG/100ML SOLUTION;INTRAPERITONEAL Discontinued None No No
DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 26MG/100ML;1.5GM/100ML;5MG/100ML;530MG/100ML;450MG/100ML SOLUTION;INTRAPERITONEAL Discontinued None No No
DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 26MG/100ML;2.5GM/100ML;5MG/100ML;530MG/100ML;450MG/100ML SOLUTION;INTRAPERITONEAL Discontinued None No No
DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE 29MG/100ML;2.5GM/100ML;15MG/100ML;610MG/100ML;560MG/100ML SOLUTION;INTRAPERITONEAL Discontinued None No No
DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 26MG/100ML;5GM/100ML;5MG/100ML;530MG/100ML;450MG/100ML SOLUTION;INTRAPERITONEAL Discontinued None No No
DIALYTE LM/ DEXTROSE 4.25% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 26MG/100ML;4.25GM/100ML;15MG/100ML;560MG/100ML;390MG/100ML SOLUTION;INTRAPERITONEAL Discontinued None No No
DIALYTE LM/ DEXTROSE 4.25% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 26MG/100ML;4.25GM/100ML;5MG/100ML;530MG/100ML;450MG/100ML SOLUTION;INTRAPERITONEAL Discontinued None No No
DIALYTE W/ DEXTROSE 1.5% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE 29MG/100ML;1.5GM/100ML;15MG/100ML;610MG/100ML;560MG/100ML SOLUTION;INTRAPERITONEAL Discontinued None No No
DIALYTE W/ DEXTROSE 4.25% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE 29MG/100ML;4.25GM/100ML;15MG/100ML;610MG/100ML;560MG/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
10/29/1981 ORIG-1 Approval Type 3 - New Dosage Form 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-30 Manufacturing (CMC)-Control

Label is not available on this site.

05/03/2000 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

02/09/1998 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

10/26/1995 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

09/13/1995 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

11/05/1991 SUPPL-24 Labeling

Label is not available on this site.

09/11/1990 SUPPL-23 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/13/1988 SUPPL-21 Labeling

Label is not available on this site.

04/19/1988 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

07/09/1987 SUPPL-19 Labeling

Label is not available on this site.

10/10/1986 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

03/05/1987 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

01/29/1986 SUPPL-14 Labeling

Label is not available on this site.

01/29/1986 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

04/03/1985 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

05/17/1985 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/31/1986 SUPPL-10 Labeling

Label is not available on this site.

01/31/1986 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

05/24/1985 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

11/02/1983 SUPPL-7 Labeling

Label is not available on this site.

11/02/1983 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

09/08/1984 SUPPL-5 Labeling

Label is not available on this site.

02/16/1983 SUPPL-4 Labeling

Label is not available on this site.

02/16/1983 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

01/25/1982 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

05/26/1982 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

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