Impax Laboratories Inc

FDA Filings

This page includes the latest FDA filings for Impax Laboratories Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

FDA Filings

Device
Company
DeviceDate
Impax Generics, Impax Laboratories, Inc, Packaging Coordinators, LLC
Prescription Medication2016-04-16
H.J. Harkins Company, Inc., Impax Laboratories Inc, Global Pharmaceuticals, Division of Impax Laboratories Inc., Impax Laboratories Taiwan Inc.
Prescription Medication2011-12-29
H.J. Harkins Company, Inc., Impax Laboratories Inc
Prescription Medication2011-08-26

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U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2018111934515Kaohsiung,China (Taiwan) -> Oakland, CaliforniaCOLESEVELAM HYDROCHLORIDE TABLETS,625MG 180CT 1320-19-0115 1745-01-0115 METAXALONE TABLETS USP 400MG 100CT 64896-663-0137653 BOT
2018110628392Kaohsiung,China (Taiwan) -> Oakland, California4422-01-0115 DANTROLENE SODIUM CAPSULES 50MG 100CT 4433-01-0115 DANTROLENE SODIUM CAPSULES 100MG 100CT 5522-02-0115 FENOFIBRATE TABLETS,160MG 500CT2899 PKG
2018110542120Kaohsiung,China (Taiwan) -> Oakland, California4422-01-0115 DANTROLENE SODIUM CAPSULES 50MG 100CT 4433-01-0115 DANTROLENE SODIUM CAPSULES 100MG 100CT 5522-02-0115 FENOFIBRATE TABLETS,160MG 500CT2899 PKG
2018102932816Kaohsiung,China (Taiwan) -> Oakland, CaliforniaFENOFIBRATE (MICRONIZED) CAPSULES,134MG 0522-01-0115 0533-02-0115 FENOFIBRATE (MICRONIZED) CAPSULES 200MG 500CT 5522-02-011555544 BOT
2018101239395Kaohsiung,China (Taiwan) -> Oakland, CaliforniaDIGOXIN TABLETS USP 0.125MG DIGOXIN TABLETS USP 0.25MG DATA LOGGER SERIAL NUMBER 2721847119 & 2721847166 IS ATTACHED TO PALLET34 DRM
2018101235497Kaohsiung,China (Taiwan) -> Oakland, CaliforniaCOLESEVELAM HYDROCHLORIDE TABLETS,625MG 180CT 1320-19-0115 64896-663-01 IPX066 ER CAPSULES 48.75MG 195MG 100CT 64896-664-0138627 BOT
2018101030652Kaohsiung,China (Taiwan) -> Oakland, CaliforniaIPX066 ER CAPSULES 23.75 95MG 100CT 64896-661-01 5522-02-0115 FENOFIBRATE TABLETS , 160MG 500CT 64896-662-0197228 BOT
201810045393Kaohsiung,China (Taiwan) -> Savannah, GeorgiaIPX066 ER CAPSULES 64896-663-01 48.75MG 195MG 100CT 64896-664-01 IPX066 ER CAPSULES 61.25MG 245MG 100CT (3004.90.99.90-4)38283 BOT

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