Product Details for: Synagis

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
For Injection
Intramuscular
50MG
Single-Dose Vial
351(a)
Synagis
Disc
002
For Injection
Intramuscular
100MG
Single-Dose Vial
351(a)
Synagis
Disc
003
Injection
Intramuscular
50MG/0.5ML
Single-Dose Vial
351(a)
Synagis
Rx
004
Injection
Intramuscular
100MG/1ML
Single-Dose Vial
351(a)
Synagis
Rx
Proper Name
palivizumab
BLA Number
103770
Applicant
Swedish Orphan Biovitrum AB (publ)
Original Approval Date
June 19, 1998
Date of First Licensure