Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018386
Company: B BRAUN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 10GM/100ML;200MG/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
07/11/1980 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
09/11/1990 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/24/1985 SUPPL-10 Labeling

Label is not available on this site.

04/03/1985 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

06/28/1985 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/18/1986 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

10/26/1981 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

12/10/1984 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

01/24/1983 SUPPL-4 Labeling

Label is not available on this site.

12/10/1980 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

12/12/1980 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

10/07/1980 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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