FLEMING LABORATORIES LTD

Overview

FLEMING LABORATORIES LTD is an active pharmaceutical ingredient (API) supplier with 1 active FDA Type II Drug Master File, covering HYDROXYZINE HYDROCHLORIDE USP.

API / Drug Master Files

FLEMING LABORATORIES LTD holds 1 active (6 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.

• HYDROXYZINE HYDROCHLORIDE USPActive2023-08-10
• ETODOLAC USPInactive2017-11-11
• CARISOPRODOL USPInactive2017-08-09
• CYCLOBENZAPRINE HYDROCHLORIDE USP BULKInactive2009-08-19
• MECLIZINE HCL USPInactive2007-04-23
• CARISOPRODOL USPInactive2006-09-26

FDA compliance signals

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