Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 013025
Company: HOSPIRA

Products on NDA 13025

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
THAM	TROMETHAMINE	18GM/500ML (3.6GM/100ML)	SOLUTION;INJECTION	Prescription	None	Yes	Yes
THAM-E	POTASSIUM CHLORIDE; SODIUM CHLORIDE; TROMETHAMINE	370MG/VIAL;1.75GM/VIAL;36GM/VIAL	INJECTABLE;INJECTION	Discontinued	None	No	No

Labels for NDA 013025

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/20/2006	SUPPL-40	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/013025s040lbl.pdf
07/20/2006	SUPPL-40	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/013025s040lbl.pdf