Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 004589
Company: B BRAUN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALCOHOL 10% AND DEXTROSE 5% ALCOHOL; DEXTROSE 10ML/100ML;5GM/100ML INJECTABLE;INJECTION Discontinued None No No
ALCOHOL 5% AND DEXTROSE 5% ALCOHOL; DEXTROSE 5ML/100ML;5GM/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
01/17/1946 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/11/1985 SUPPL-11 Labeling

Label is not available on this site.

06/14/1985 SUPPL-10 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/09/1984 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

10/04/1982 SUPPL-6 Labeling

Label is not available on this site.

01/19/1982 SUPPL-5 Labeling

Label is not available on this site.

10/01/1980 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

02/16/1978 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

06/28/1977 SUPPL-2 Labeling

Label is not available on this site.

06/28/1977 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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