Lantheus Medical Imaging Inc

FDA Filings

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

FDA Registration(s)

• Registration Number: 1216602
• FEI Number: 1216602
• Name: LANTHEUS MEDICAL IMAGING, Inc.
• Owner & Operator: LANTHEUS MEDICAL IMAGING, INC.
• Contact Address: 331 Treble Cove Road BLDG 300-2; N Billerica MA 01862 US
• Official Correspondent:
  • Cindy - Warwick
  • x-978-6718472-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 331 TREBLE COVE RD BLDG 300-2; N Billerica, MA 01862 US
• Establishment Type:
  • Manufacture Medical Device
  • Repack or Relabel Medical Device

FDA Filings

Device Company	Device	Date
Definity Lantheus Medical Imaging, Inc., Jubilant HollisterStier	Prescription Medication	2024-03-16
DEFINITY RT Lantheus Medical Imaging, Inc., Samsung Biologics Co, LTD	Prescription Medication	2024-03-16
Definity Lantheus Medical Imaging, Inc., Jubilant HollisterStier	Prescription Medication	2023-11-08
Definity Lantheus Medical Imaging, Inc., Jubilant HollisterStier	Prescription Medication	2023-08-19
Definity Lantheus Medical Imaging, Inc., Jubilant HollisterStier	Prescription Medication	2023-06-15
DEFINITY RT Lantheus Medical Imaging, Inc., Samsung Biologics Co, LTD	Prescription Medication	2023-06-15
TechneLite Lantheus Medical Imaging, Inc., NTP RADIOISOTOPES PTY LTD, INSTITUT NATIONAL DES RADIOELEMENTS IRE, AUSTRALIAN NUCLEAR SCIENCE AND TECHNOLOGY ORGANIZATION DBA AUSTRALIAN RADIOPHARMACEUTICAL AND INDUSTRIALS	Prescription Medication	2023-02-02
Cardiolite Lantheus Medical Imaging, Inc., Jubilant HollisterStier LLC	Prescription Medication	2022-12-08
Thallous Chloride Tl 201 Lantheus Medical Imaging, Inc.	Prescription Medication	2022-11-30
Xenon Lantheus Medical Imaging, Inc., Institut National des Radioelements	Prescription Medication	2022-11-30
NEUROLITE Lantheus Medical Imaging, Inc., Jubilant HollisterStier	Prescription Medication	2022-11-29
Kit for the Preparation of Technetium Tc99m Sestamibi Lantheus Medical Imaging, Inc., Jubilant HollisterStier LLC	Prescription Medication	2022-11-23
Gallium Lantheus Medical Imaging, Inc.	Prescription Medication	2022-11-19
Definity Lantheus Medical Imaging, Inc., Jubilant HollisterStier	Prescription Medication	2022-11-18
NEUROLITE Lantheus Medical Imaging, Inc., Jubilant HollisterStier	Prescription Medication	2021-10-20
DEFINITY RT Lantheus Medical Imaging, Inc., Samsung Biologics Co, LTD	Prescription Medication	2021-06-26
DEFINITY RT Lantheus Medical Imaging, Inc., Samsung Biologics Co, LTD	Prescription Medication	2021-04-24
Definity Lantheus Medical Imaging, Inc., Jubilant HollisterStier	Prescription Medication	2021-04-21
Thallous Chloride Tl 201 Lantheus Medical Imaging, Inc.	Prescription Medication	2020-11-26
DEFINITY RT Lantheus Medical Imaging, Inc., Samsung Biologics Co, LTD	Prescription Medication	2020-11-25
TechneLite Lantheus Medical Imaging, Inc., NTP RADIOISOTOPES PTY LTD, INSTITUT NATIONAL DES RADIOELEMENTS IRE, AUSTRALIAN NUCLEAR SCIENCE AND TECHNOLOGY ORGANIZATION DBA AUSTRALIAN RADIOPHARMACEUTICAL AND INDUSTRIALS	Prescription Medication	2020-11-20
Xenon Lantheus Medical Imaging, Inc., Institut National des Radioelements	Prescription Medication	2020-11-18
Gallium Lantheus Medical Imaging, Inc.	Prescription Medication	2020-11-17
NDC 11994-017 Lantheus Medical Imaging, Inc.	DEFINITY RT	2020-10-01
GUDID 00866709000402 LANTHEUS MEDICAL IMAGING, INC.	VIALMIX®RFID VMIX2	2020-09-23
Definity Lantheus Medical Imaging, Inc., Jubilant HollisterStier	Prescription Medication	2020-09-17
Definity Lantheus Medical Imaging, Inc., Jubilant HollisterStier	Prescription Medication	2020-08-12
Kit for the Preparation of Technetium Tc99m Sestamibi Lantheus Medical Imaging, Inc., Jubilant HollisterStier LLC	Prescription Medication	2020-06-25
Fludeoxyglucose F-18 Lantheus Medical Imaging, Inc., Lantheus MI Radiopharmaceuticals, Inc.	Prescription Medication	2020-06-25
Cardiolite Lantheus Medical Imaging, Inc., Jubilant HollisterStier LLC	Prescription Medication	2019-12-13
Fludeoxyglucose F-18 Lantheus Medical Imaging, Inc., Lantheus MI Radiopharmaceuticals, Inc.	Prescription Medication	2019-12-06
NEUROLITE Lantheus Medical Imaging, Inc., Jubilant HollisterStier	Prescription Medication	2019-11-22
TechneLite Lantheus Medical Imaging, Inc., NTP RADIOISOTOPES PTY LTD, INSTITUT NATIONAL DES RADIOELEMENTS IRE, AUSTRALIAN NUCLEAR SCIENCE AND TECHNOLOGY ORGANIZATION DBA AUSTRALIAN RADIOPHARMACEUTICAL AND INDUSTRIALS	Prescription Medication	2019-11-22
Xenon Lantheus Medical Imaging, Inc., Institut National des Radioelements	Prescription Medication	2019-03-16
Definity Lantheus Medical Imaging, Inc., Jubilant HollisterStier	Prescription Medication	2018-12-19
Gallium Lantheus Medical Imaging, Inc.	Prescription Medication	2018-06-07
Thallous Chloride Tl 201 Lantheus Medical Imaging, Inc.	Prescription Medication	2018-05-23
TechneLite Lantheus Medical Imaging, Inc., NTP RADIOISOTOPES PTY LTD, INSTITUT NATIONAL DES RADIOELEMENTS IRE, AUSTRALIAN NUCLEAR SCIENCE AND TECHNOLOGY ORGANIZATION DBA AUSTRALIAN RADIOPHARMACEUTICAL AND INDUSTRIALS	Prescription Medication	2018-05-11
NEUROLITE Lantheus Medical Imaging, Inc., Jubilant HollisterStier	Prescription Medication	2018-04-28
Quadramet Lantheus Medical Imaging, Inc.	Prescription Medication	2018-03-22
Kit for the Preparation of Technetium Tc99m Sestamibi Lantheus Medical Imaging, Inc., Jubilant HollisterStier LLC	Prescription Medication	2017-10-27
Cardiolite Lantheus Medical Imaging, Inc., Jubilant HollisterStier LLC	Prescription Medication	2017-10-27
Fludeoxyglucose F-18 Lantheus Medical Imaging, Inc., Lantheus MI Radiopharmaceuticals, Inc.	Prescription Medication	2014-02-13
NDC 11994-015 Lantheus Medical Imaging, Inc.	Fludeoxyglucose F-18	2014-02-04
EFD LANTHEUS MEDICAL IMAGING, Inc.	VIALMIX	2002-04-24
NDC 11994-011 Lantheus Medical Imaging, Inc.	Definity	2001-07-31
NDC 11994-016 Lantheus Medical Imaging, Inc.	Quadramet	1997-05-19
NDC 11994-006 Lantheus Medical Imaging, Inc.	NEUROLITE	1994-11-23
IXD LANTHEUS MEDICAL IMAGING, Inc.	SAMARIUM SM-153	1992-08-15
NDC 11994-003 Lantheus Medical Imaging, Inc.	Kit For The Preparation Of Technetium Tc99m Sestamibi	1990-12-20
NDC 11994-001 Lantheus Medical Imaging, Inc.	Cardiolite	1990-12-20
NDC 11994-427 Lantheus Medical Imaging, Inc.	Thallous Chloride Tl 201	1977-12-16
NDC 11994-121 Lantheus Medical Imaging, Inc.	Gallium	1976-05-17
NDC 11994-091 Lantheus Medical Imaging, Inc.	TechneLite	1975-11-01
NDC 11994-090 Lantheus Medical Imaging, Inc.	TechneLite	1975-11-01
NDC 11994-128 Lantheus Medical Imaging, Inc.	Xenon	1974-10-10
NDC 11994-127 Lantheus Medical Imaging, Inc.	Xenon	1974-10-10

Similar & Related FDA Registered Companies

• Jubilant HollisterStier
• Samsung Biologics Co, LTD
• NTP RADIOISOTOPES PTY LTD
• INSTITUT NATIONAL DES RADIOELEMENTS IRE
• AUSTRALIAN NUCLEAR SCIENCE AND TECHNOLOGY ORGANIZATION DBA AUSTRALIAN RADIOPHARMACEUTICAL AND INDUSTRIALS
• Jubilant HollisterStier LLC
• Institut National des Radioelements
• Lantheus MI Radiopharmaceuticals, Inc.

Related Finance Registrations

NCAGE Code	1YCS9	LANTHEUS MEDICAL IMAGING, INC.
CAGE Code	1YCS9	LANTHEUS MEDICAL IMAGING, INC.
S.A.M. Registration	1YCS9 [176786812]	LANTHEUS MEDICAL IMAGING, INC.
SEC	0001500157	Lantheus Medical Imaging, Inc. of DELAWARE

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2019042457934	Bremerhaven,Federal Republic of Germany -> Boston, Massachusetts	S.T.C.DENTAL MATERIALH.S.CODE: 84798997	10 PAL
201902275311	Bremerhaven,Federal Republic of Germany -> New York, New York	1 ONE OPTIMA VIAL-FILLING-LINE, COMPLETE, W ITH ACCESSORIES CUSTOMS BROKER OCEAN AIR CHB	2 PCS
2019012224186	Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	. . . . .	11 PKG
2019012224186	Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	. . . . .	11 PKG
2019012224186	Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	. . . . .	11 PKG
2019012224186	Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	. . . . .	11 PKG
2019012224186	Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	. . . . .	11 PKG
2018121144622	Bremerhaven,Federal Republic of Germany -> Boston, Massachusetts	DENTAL MATERIALHS CODE: 84798997	11 PKG
2018111631675	Bremerhaven,Federal Republic of Germany -> Boston, Massachusetts	S.T.C.MEDICAL EQUIPMENTH.S.CODE: 84798997	10 PKG
2018102438382	Bremerhaven,Federal Republic of Germany -> Boston, Massachusetts	S.T.C.DENTAL MATERIALH.S.CODE: 84798997	10 PKG
2018102438382	Bremerhaven,Federal Republic of Germany -> Boston, Massachusetts	S.T.C.DENTAL MATERIALH.S.CODE: 84798997	10 PKG
2018102438382	Bremerhaven,Federal Republic of Germany -> Boston, Massachusetts	S.T.C.DENTAL MATERIALH.S.CODE: 84798997	10 PKG
2018041740586	Bremerhaven,Federal Republic of Germany -> Boston, Massachusetts	S.T.C.DENTAL MATERIALH.S.CODE: 84798997	10 PKG
2018041741075	Bremerhaven,Federal Republic of Germany -> Boston, Massachusetts	ALICYCLIC KETONES(MS-325074,4-DIPHENYL-2-CYCL OHEXENE-1-ON	2 PKG