Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018186
Company: B BRAUN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SODIUM LACTATE 0.167 MOLAR IN PLASTIC CONTAINER SODIUM LACTATE 1.87GM/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
06/15/1979 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
03/24/1993 SUPPL-16 Labeling

Label is not available on this site.

09/11/1990 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

06/24/1985 SUPPL-13 Labeling

Label is not available on this site.

04/03/1985 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

06/28/1985 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

02/18/1986 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

10/26/1981 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

02/24/1981 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

01/24/1983 SUPPL-7 Labeling

Label is not available on this site.

09/25/1980 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

10/24/1980 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

08/06/1980 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

02/12/1980 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

10/09/1979 SUPPL-2 Labeling

Label is not available on this site.

10/16/1979 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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