JANSSEN ORTHO LLC

Overview

JANSSEN ORTHO LLC is an active pharmaceutical ingredient (API) supplier with 1 active FDA Type II Drug Master File, covering RIVAROXABAN 10 MG FILM COATED TABLETS.

API / Drug Master Files

JANSSEN ORTHO LLC holds 1 active (1 total) FDA Type II Drug Master File — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.

• RIVAROXABAN 10 MG FILM COATED TABLETSActive2008-07-24

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to JANSSEN ORTHO LLC in our records. PharmaTek screens the full directory against live FDA enforcement data.