Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017995
Company: B BRAUN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEXTROSE 60% DEXTROSE 60GM/100ML INJECTABLE;INJECTION Discontinued None No No
DEXTROSE 60% IN PLASTIC CONTAINER DEXTROSE 60GM/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
04/24/1978 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
05/16/1985 SUPPL-5 Labeling

Label is not available on this site.

09/22/1982 SUPPL-2 Labeling

Label is not available on this site.

05/04/1981 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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