Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018494
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 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
02/19/1982 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
09/26/2014 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

09/30/2014 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

04/26/2013 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

09/14/1993 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

09/30/1994 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

01/10/1991 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

03/26/1991 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

11/14/1991 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/26/1989 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

10/30/1986 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

06/26/1985 SUPPL-7 Labeling

Label is not available on this site.

02/28/1984 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

01/24/1985 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

05/07/1982 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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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