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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075323
Company: BAXTER HLTHCARE

Products on ANDA 075323

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075323

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.

Therapeutic Equivalents for ANDA 075323

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
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	214623	FRESENIUS KABI USA
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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