Product Details for: Rotarix

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
For Suspension
Oral
1ML
Single-Dose Vial
351(a)
Rotarix
Disc
002
Suspension
Oral
106.0CCID50
Tube
351(a)
Rotarix
Disc
003
Suspension
Oral
106.0CCID50
Oral Applicator
351(a)
Rotarix
Rx
Proper Name
Rotavirus Vaccine, Live, Oral
BLA Number
125265
Applicant
GlaxoSmithKline Biologicals
Original Approval Date
April 3, 2008
Date of First Licensure
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