Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020000
Company: B BRAUN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEXTROSE 5% IN RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 33MG/100ML;5GM/100ML;30MG/100ML;860MG/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
04/17/1992 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
12/01/2003 SUPPL-11 Labeling

Label is not available on this site.

06/18/2003 SUPPL-10 Labeling

Label is not available on this site.

07/01/2002 SUPPL-9 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

04/15/2002 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/07/2000 SUPPL-6 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

08/21/1998 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

07/21/1993 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

05/10/1993 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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