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Product Approval Information - Licensing Action

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Proper name: BCG Live
Tradename: TICE BCG
Manufacturer: Organon Teknika Corp, Durham, NC License #0956
Indication for Use: Expand the indication for intravesical instillation, to include adjunct treatment of stage Ta or Tl papillary tumors of the bladder
Approval Date: 8/21/1998
Type of submission: Biologics license application supplement

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Approval Letter - (PDF), (Text)

SBA - (PDF)

 

 
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