Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018046
Company: B BRAUN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEXTROSE 10% IN PLASTIC CONTAINER DEXTROSE 10GM/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
02/21/1978 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
09/11/1990 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

06/25/1985 SUPPL-18 Labeling

Label is not available on this site.

04/03/1985 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

05/17/1985 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

02/18/1986 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

10/26/1981 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

01/24/1983 SUPPL-13 Labeling

Label is not available on this site.

10/24/1980 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

08/06/1980 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

07/16/1980 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

02/12/1980 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

10/09/1979 SUPPL-8 Labeling

Label is not available on this site.

10/16/1979 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

06/08/1979 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

06/07/1979 SUPPL-5 Labeling

Label is not available on this site.

06/07/1979 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

11/30/1978 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

09/29/1978 SUPPL-2 Labeling

Label is not available on this site.

03/23/1978 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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