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CARDIOPLEGIC IN PLASTIC CONTAINER از شرکت BAXTER HLTHCARE

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CARDIOPLEGIC IN PLASTIC CONTAINER از شرکت BAXTER HLTHCARE

Abbreviated New Drug Application (ANDA): 075323

Company: BAXTER HLTHCARE

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CARDIOPLEGIC IN PLASTIC CONTAINER CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/100ML SOLUTION;PERFUSION, CARDIAC 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
04/21/2000 ORIG-1 Approval

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75323ltr.pdf

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/04/2016 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

CARDIOPLEGIC IN PLASTIC CONTAINER

SOLUTION;PERFUSION, CARDIAC; 17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/100ML

TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARDIOPLEGIC IN PLASTIC CONTAINER CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/100ML SOLUTION;PERFUSION, CARDIAC Prescription No AT 075323 BAXTER HLTHCARE
PLEGISOL IN PLASTIC CONTAINER CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/100ML SOLUTION;PERFUSION, CARDIAC Prescription Yes AT 018608 HOSPIRA
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