Product Approval Information - Licensing Action
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
Approval Letter -
(PDF),
(Text)
SBA - (PDF)
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