Mallinckrodt

FDA Filings

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

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
022231 NDA MALLINCKRODT		2022-09-20 18:47:54
089725 ANDA MALLINCKRODT		0000-00-00 00:00:00
089405 ANDA MALLINCKRODT		0000-00-00 00:00:00
089160 ANDA MALLINCKRODT		0000-00-00 00:00:00
089102 ANDA MALLINCKRODT		0000-00-00 00:00:00
089023 ANDA MALLINCKRODT		0000-00-00 00:00:00
089006 ANDA MALLINCKRODT		0000-00-00 00:00:00
088991 ANDA MALLINCKRODT		0000-00-00 00:00:00
088956 ANDA MALLINCKRODT		0000-00-00 00:00:00
088758 ANDA MALLINCKRODT		0000-00-00 00:00:00
087336 ANDA MALLINCKRODT		0000-00-00 00:00:00
087075 ANDA MALLINCKRODT		0000-00-00 00:00:00
087074 ANDA MALLINCKRODT		0000-00-00 00:00:00
087073 ANDA MALLINCKRODT		0000-00-00 00:00:00
077822 ANDA MALLINCKRODT		0000-00-00 00:00:00
075738 ANDA MALLINCKRODT		0000-00-00 00:00:00
075726 ANDA MALLINCKRODT		0000-00-00 00:00:00
040550 ANDA MALLINCKRODT		0000-00-00 00:00:00
040468 ANDA MALLINCKRODT		0000-00-00 00:00:00
040418 ANDA MALLINCKRODT		0000-00-00 00:00:00
040257 ANDA MALLINCKRODT		0000-00-00 00:00:00
040201 ANDA MALLINCKRODT		0000-00-00 00:00:00
040084 ANDA MALLINCKRODT		0000-00-00 00:00:00
018536 NDA MALLINCKRODT		0000-00-00 00:00:00
017725 NDA MALLINCKRODT		0000-00-00 00:00:00
017724 NDA MALLINCKRODT		0000-00-00 00:00:00
017685 NDA MALLINCKRODT		0000-00-00 00:00:00
017551 NDA MALLINCKRODT		0000-00-00 00:00:00
017454 NDA MALLINCKRODT		0000-00-00 00:00:00
017262 NDA MALLINCKRODT		0000-00-00 00:00:00
017129 NDA MALLINCKRODT		0000-00-00 00:00:00
017098 NDA MALLINCKRODT		0000-00-00 00:00:00
017059 NDA MALLINCKRODT		0000-00-00 00:00:00
016783 NDA MALLINCKRODT		0000-00-00 00:00:00
016729 NDA MALLINCKRODT		0000-00-00 00:00:00
016666 NDA MALLINCKRODT		0000-00-00 00:00:00
014295 NDA MALLINCKRODT		0000-00-00 00:00:00
013319 NDA MALLINCKRODT		0000-00-00 00:00:00
011777 NDA MALLINCKRODT		0000-00-00 00:00:00

Similar & Related FDA Registered Companies

• Mallinckrodt Pharmaceuticals
• Mallinckrodt Hospital Products Inc.
• Mallinckrodt Hospital Products IP Limited
• Mallinckrodt Pharmaceuticals Ireland Ltd
• Mallinckrodt Manufacturing LLC
• MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS
• MALLINCKRODT DEVELOPPEMENT FRANCE
• MALLINCKRODT MEDICAL
• MALLINCKRODT DAR S.R.L.
• MALLINCKRODT, INC.
• Mallinckrodt Medical, Inc.
• MALLINCKRODT SENSOR SYSTEMS, INC.
• MALLINCKRODT GROUP, INC.
• MALLINCKRODT MEDICAL TPI, INC.
• MALLINCKRODT ANESTHESIA PRODUCTS
• MALLINCKRODT CRITICAL CARE
• 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 ARD LLC
• Mallinckrodt Baker Inc.
• Mallinckrodt Inc (Brand Pharmaceuticals)
• Mallinckrodt Inc. (Coviden)
• MALLINCKRODT NUCLEAR MEDICINE LLC

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
20200821301	Stadersand,Federal Republic of Germany -> Norfolk, Virginia	OFIRMEV (ACETAMINOPHEN 10MG ML), 100M TEMPERATURE 23 DEGR.C DELIVERY 3514421634 LOADED ON 9 PALLETS HS-CODE 30049008	27216 PCS
20200821301	Stadersand,Federal Republic of Germany -> Norfolk, Virginia	OFIRMEV (ACETAMINOPHEN 10MG ML, 100M TEMPERATURE 23 DEGR.C DELIVERY 3514421530 LOADED ON 9 PALLETS HS-CODE 30049008	27216 PCS
2019053041434	Stadersand,Federal Republic of Germany -> Norfolk, Virginia	OFIRMEV (ACETAMINOPHEN 10MG ML), 100M TEMPERATURE 23 DEGR.C DELIVERY 3514421634 LOADED ON 9 PALLETS HS-CODE 30049008	27216 PCS
2019053041434	Stadersand,Federal Republic of Germany -> Norfolk, Virginia	OFIRMEV (ACETAMINOPHEN 10MG ML, 100M TEMPERATURE 23 DEGR.C DELIVERY 3514421530 LOADED ON 9 PALLETS HS-CODE 30049008	27216 PCS
2019051739936	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	OFIRMEV (ACETAMINOPHEN 10MG ML), 100ML TEMPERATURE 23DEGR C DELIVERY 3514421698 LOADED ON 12 PALLETS HS-CODE 30049008	18336 PCS
2019051662877	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	OFIRMEV (ACETAMINOPHEN 10MG ML), 100ML TEMPERATURE 23DEGR C DELIVERY 3514421698 LOADED ON 12 PALLETS HS-CODE 30049008	18336 PCS
2019051442098	Stadersand,Federal Republic of Germany -> New York, New York	OFIRMEV (ACETAMINOPHEN 10MG ML), 100ML TEMPERATURE 23 DEGR.C DELIVERY 3514297887 HS-CODE 30049008	19392 PCS
2019051442098	Stadersand,Federal Republic of Germany -> New York, New York	OFIRMEV (ACETAMINOPHEN 10MG ML), 100ML TEMPERATURE 23 DEGR.C DELIVERY 3514317440 LOADED ON 12 PALLETS HS-CODE 30049008	19392 PCS
2018080939442	Anvers,Belgium -> Savannah, Georgia	8 PACKAGES METHYL VENYL KETONE HS CODE 2914.19 . SUBJECT TO IMDG CODE UN1251 METHYL VINYL KETONE, STABILIZED,	8 PKG
2018010413759	Mundra,India -> New York/Newark Area, Newark, New Jersey	HS CODE 29173990 DIMETHYL 5-NITROISOPHTHALATE	40 BAG
201801011484	Mundra,India -> New York/Newark Area, Newark, New Jersey	HS CODE 29173990 DIMETHYL 5-NITROISOPHTHALATE	40 BAG