Proper Name: Tuberculin, Purified Protein Derivative
Manufacturer: Sanofi Pasteur Limited, License #1726
- To aid diagnosis of tuberculosis infection (TB) in persons at increased risk of developing active disease
April 22, 2016 Approval Letter - TUBERSOL(PDF - 38KB)
To update the package insert to remove ‘Pregnancy Category C’ and to include revisions to the Pediatric Use section and other minor editorial revisions.
February 22, 2013 Approval Letter- TUBERSOL
To revise the package insert to include two additional adverse events from post-marketing experience and other minor changes and to revise the carton and container labeling to include a 2D barcode and a revised company logo.
FDA Online Label Repository
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