Product Details for: Rotateq

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Suspension
Oral
2.2X10E6 IU
Tube
351(a)
Rotateq
Rx
002
Suspension
Oral
2.2X10E6 IU
Ampule
351(a)
Rotateq
Rx
Proper Name
Rotavirus Vaccine, Live, Oral, Pentavalent
BLA Number
125122
Applicant
Merck Sharp & Dohme LLC
Original Approval Date
February 3, 2006
Date of First Licensure
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