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Vaccines, Blood & Biologics
TICE BCG
Proper Name: BCG Live
Tradename: TICE BCG
Manufacturer: Organon Teknika Corp., LLC, License #1747
Indication:
- To expand the indication for intravesical instillation, to include adjunct treatment of stage Ta or T1 papillary tumors of the bladder.
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Supporting Documents
- October 8, 2009 Approval Letter
To include a reconstitution accessory kit as a second option for reconstitution. - August 21, 1998 Approval Letter - BCG Vaccine
To expand the indication for intravesical instillation, to include adjunct treatment of stage Ta or T1 papillary tumors of the bladder. - Summary for Basis of Approval - BCG Vaccine (PDF - 1069KB)
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Contact Us
Consumer Affairs Branch (CBER)
- (800) 835-4709
- (301) 827-1800
- ocod@fda.hhs.gov
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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