Home PurpleBook 125835 mnexspike Purple Book BLA 125835
BLA number 125835
Proprietary names mnexspike
Proper names COVID-19 Vaccine, mRNA
Applicant ModernaTX, Inc.
Center CBER
First observed release 2025-06-01
Latest observed release 2026-06-01
Newest archive release 2026-06-01
FDA patent list No patents listed in the captured FDA patent list; source updated 2025-06-11
Coverage Present in newest release Latest Known Product Presentations# Product, Proprietary name, Proper name table Product Proprietary name Proper name License type Strength Dosage form Route Presentation Marketing Licensure Approval Patent list provided 001 mnexspike COVID-19 Vaccine, mRNA 351(a) 10UG Injection Intramuscular Pre-Filled Syringe Rx Licensed 2025-05-30
Published Patent List# No patents for this BLA were listed in the FDA Purple Book patent list captured from the source updated 2025-06-11.
Official Monthly Change Events# Release, Event, Product table Release Event Product Name License type Status Applicant 2025-06-01 N 001 mnexspike 351(a) Rx ModernaTX, Inc.
Observed Product State History# Release, Product, Name table Release Product Name License type Marketing Licensure Approval 2025-06-01 001 mnexspike 351(a) Rx Licensed 2025-05-30
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