Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018681
Company: B BRAUN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LACTATED RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML SOLUTION;IRRIGATION Prescription AT Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/27/1982 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
09/02/2014 SUPPL-27 Labeling-Container/Carton Labels Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018681s027lbl.pdf
05/31/2007 SUPPL-19 Labeling

Label is not available on this site.

08/21/2002 SUPPL-18 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/10/2002 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

06/25/1998 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

04/04/1995 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

09/11/1990 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

04/19/1988 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

11/13/1985 SUPPL-8 Labeling

Label is not available on this site.

07/16/1985 SUPPL-7 Labeling

Label is not available on this site.

03/05/1987 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

04/03/1985 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

03/18/1985 SUPPL-3 Labeling

Label is not available on this site.

03/18/1985 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

01/19/1985 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/02/2014 SUPPL-27 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018681s027lbl.pdf

LACTATED RINGER'S IN PLASTIC CONTAINER

SOLUTION;IRRIGATION; 20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LACTATED RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML SOLUTION;IRRIGATION Prescription Yes AT 018681 B BRAUN
LACTATED RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML SOLUTION;IRRIGATION Prescription No AT 018494 BAXTER HLTHCARE
LACTATED RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML SOLUTION;IRRIGATION Prescription Yes AT 018921 BAXTER HLTHCARE
LACTATED RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML SOLUTION;IRRIGATION Prescription Yes AT 019416 ICU MEDICAL INC

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