K251580

Substantially Equivalent

MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD)

Applicant: Liofilchem s.r.l.
Product code: JWY
Advisory panel: Microbiology
Date received: 2025-05-23
Decision date: 2025-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Roseto Degli Abruzzi, IT

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