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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

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Tuberculin, Purified Protein Derivative - Tubersol

STN# 103941
Proper Name: Tuberculin, Purified Protein Derivative
Tradename: Tubersol
Manufacturer: Sanofi Pasteur Limited, License #1726
Indication: 

  • To aid diagnosis of tuberculosis infection (TB) in persons at increased risk of developing active disease 
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Supporting Documents

  • 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.
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Related Information

  • FDA Online Label Repository
    Search this database for drug labeling and other information. The content has not been altered or verified by the FDA and may not be the labeling on currently distributed products or identical to the labeling that is approved.
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Contact FDA

(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448
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