Mallinckrodt Pharmaceuticals

FDA Filings

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

Mallinckrodt Pharmaceuticals holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• MALLINCKRODT PHARMACEUTICALS IRELAND LTD

FDA Owner/Operator Registration

Similar & Related FDA Registered Companies

• Mallinckrodt Pharmaceuticals Ireland Ltd
• Mallinckrodt Pharmaceuticals Ireland Limitedcollege Business & Technology Parkcruiserath Roadblanchardstown D15 T PMA NumberP860003 Supplement NumberS108 Date Received08/26/2022 Decision Date09/23/2022 Product Code LNR  Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Mallinckrodt Pharmaceuticals Ireland Limitedcollege Business & Technology Parkcruiserath Roadblanchardstown D15 T PMA NumberP860003 Supplement NumberS107 Date Received04/27/2022 Decision Date05/25/2022 Product Code LNR  Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Mallinckrodt Pharmaceuticals Ireland Limitedcollege Business & Technology Parkcruiserath Roadblanchardstown D15 T PMA NumberP860003 Supplement NumberS106 Date Received02/09/2022 Decision Date03/11/2022 Product Code LNR  Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Mallinckrodt Inc (Brand Pharmaceuticals)

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020062031566	London,United Kingdom -> Houston, Texas	UN1956 CLASS 2.2	20 PCS
2020061236673	London,United Kingdom -> Houston, Texas	UN1956 CLASS 2.2	20 PCS
2020012352	London,United Kingdom -> Houston, Texas	COMPRESSED GAS HAZ CL 2 UN 1956	1 PKG
2020011457	London,United Kingdom -> Houston, Texas	COMPRESSED GAS HAZ CL 2 UN 1956	1 PKG
2020011045150	London,United Kingdom -> Houston, Texas	GAS CYLINDERS HAZ CLASS 2.2	6 PCS
20200108104	London,United Kingdom -> Houston, Texas	COMPRESSED GAS HAZ CL 2 UN 1956	1 PKG
20200107334	London,United Kingdom -> Houston, Texas	COMPRESSED GAS HAZ CL 2 UN 1956	1 PKG
20191228237	London,United Kingdom -> Houston, Texas	COMPRESSED GAS HAZ CL 2 UN 1956	1 PKG