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Tice Bcg
BCG Live
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Tice Bcg
Proper name
BCG Live
Licence type
351(a)
BLA number
102821
Applicant
Merck Teknika LLC
Center
CBER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 100-800 MIL CFU | For Injection | Intravesical | Single-Dose Vial | Rx | June 21, 1989 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |