Product Details for: Gardasil 9

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intramuscular
0.5ML
Pre-Filled Syringe
351(a)
Gardasil 9
Rx
002
Injection
Intramuscular
0.5ML
Single-dose vial
351(a)
Gardasil 9
Rx
Proper Name
Human Papillomavirus 9-valent Vaccine, Recombinant
BLA Number
125508
Applicant
Merck Sharp & Dohme LLC
Original Approval Date
December 10, 2014
Date of First Licensure
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