IDT AUSTRALIA LTD

Overview

IDT AUSTRALIA LTD is an active pharmaceutical ingredient (API) supplier with 5 active FDA Type II Drug Master Files, covering ACETAZOLAMIDE USP; HEMATOPORPHYRIN DIACETATE; MINOCYCLINE HYDROCHLORIDE USP; MITOXANTRONE HYDROCHLORIDE USP; THIOTEPA USP.

API / Drug Master Files

IDT AUSTRALIA LTD holds 5 active (5 total) FDA Type II Drug Master Files — 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.

• MINOCYCLINE HYDROCHLORIDE USPActive2000-10-02
• HEMATOPORPHYRIN DIACETATEActive2000-04-24
• THIOTEPA USPActive1999-06-01
• ACETAZOLAMIDE USPActive1998-05-21
• MITOXANTRONE HYDROCHLORIDE USPActive1997-01-20

FDA compliance signals

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