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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018921
Company: BAXTER HLTHCARE

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
04/03/1984 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
09/30/2014 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.
09/29/2015 SUPPL-31 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018921s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018921Orig1s031ltr.pdf
08/29/2001 SUPPL-22 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.
01/28/2000 SUPPL-21 Manufacturing (CMC)-Packaging

Label is not available on this site.
05/26/1999 SUPPL-20 Labeling

Label is not available on this site.
04/29/1997 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.
02/18/1994 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.
09/30/1994 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.
12/08/1993 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.
05/08/1991 SUPPL-13 Labeling

Label is not available on this site.
01/22/1991 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.
03/26/1991 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.
02/15/1991 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.
07/26/1989 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.
01/12/1989 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.
07/25/1987 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.
05/28/1987 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.
02/27/1986 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.
04/26/1985 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.
06/13/1985 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
09/29/2015 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018921s031lbl.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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