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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Tablet
Oral
4.5LOG 10TCID
Bottle
351(a)
N/A
Rx
Proper Name
Adenovirus Type 4 and Type 7 Vaccine, Live, Oral
Adenovirus Type 4 and Type 7 Vaccine, Live, Oral
BLA Number
125296
125296
Applicant
Teva Women's Health, Inc.
Teva Women's Health, Inc.
Original Approval Date
March 16, 2011
March 16, 2011
Date of First Licensure