Vaccines, Blood & Biologics
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BCG Vaccine
STN: 103050
Proper Name: BCG Live
Tradename: BCG Vaccine
Manufacturer: Organon Teknika Corp., LLC
Indication: For the prevention of tuberculosis in persons not previously infected with M. tuberculosis who are at high risk for exposure.
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Supporting Documents
January 13, 2011 Approval Letter - BCG Vaccine
An instruction sheet included for the multi-puncture administration device supplied separately for use with the product.December 16, 2010 Approval Letter - BCG Live (TICE® BCG) and BCG Vaccine To include revisions to the post-marketing routine stability study protocol.
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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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