Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019933
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 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
08/29/1989 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
06/15/2007 SUPPL-10 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

08/14/2001 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

12/07/2000 SUPPL-6 Labeling

Label is not available on this site.

02/18/1994 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

09/30/1994 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

04/26/1991 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

10/05/1993 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

03/26/1991 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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