Merz Pharma G M B H Co Kgaa

FDA Filings

This page includes the latest FDA filings for Merz Pharma G M B H Co Kgaa. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3006999111
FEI Number3006999111
NameMERZ PHARMA GMBH & CO. KGAA
Owner & OperatorMerz Pharma GmbH & Co. KGaA
Contact AddressLudwigstrasse 22
Reinheim DE-NOTA 64354 DE
Official Correspondent
  • Simone Ganzmann
  • 49-61-628009750-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressLudwigstrasse 22
Reinheim Hessen, 64354 DE
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)



FDA Filings

Device
Company
DeviceDate
Pharma Packaging Solutions, LLC dba Tjoapack LLC, Merz Pharma GmbH & Co. KGaA
Otc Medication2024-03-16
Solstice Neurosciences, LLC, MDD US Operations, LLC, Catalent Pharma Solutions, LLC, Eurofins Lancaster Laboratories, Inc., IDT Biologica GmbH, Merz Pharma GmbH & Co. KGaA, Pacific BioLabs
Prescription Medication2023-12-21
HRA PHARMA AMERICA, INC.
Otc Medication2023-12-01
HRA PHARMA AMERICA, INC.
Otc Medication2023-11-07
HRA PHARMA AMERICA, INC.
Otc Medication2023-11-07
HRA PHARMA AMERICA, INC.
Otc Medication2023-11-04
HRA PHARMA AMERICA, INC.
Otc Medication2023-11-03
Merz Pharmaceuticals, LLC, Merz Pharma GmbH & Co. KGaA
Prescription Medication2023-09-23
Merz North America, Inc., Merz Pharma GmbH & Co. KGaA
Prescription Medication2023-09-20
HRA Pharma America, Inc., Merz Pharma GmbH & Co KGaA
Otc Medication2022-10-29
Solstice Neurosciences, LLC, MDD US Operations, LLC, Catalent Pharma Solutions, LLC, Eurofins Lancaster Laboratories, Inc., IDT Biologica GmbH, Merz Pharma GmbH & Co. KGaA, Pacific BioLabs
Prescription Medication2022-10-15
Merz Pharmaceuticals, LLC, Merz Pharma GmbH & Co. KGaA
Prescription Medication2022-09-13
Merz North America, Inc., Merz Pharma GmbH & Co. KGaA
Prescription Medication2022-09-13
Solstice Neurosciences, LLC, MDD US Operations, LLC, Catalent Pharma Solutions, LLC, Eurofins Lancaster Laboratories, Inc., IDT Biologica GmbH, Merz Pharma GmbH & Co. KGaA, Pacific BioLabs
Prescription Medication2022-06-26
HRA PHARMA AMERICA, INC.
Otc Medication2022-03-09
Merz Pharmaceuticals, LLC, Merz Pharma GmbH & Co. KGaA
Prescription Medication2021-08-26
Merz North America, Inc., Merz Pharma GmbH & Co. KGaA
Prescription Medication2021-08-26
HRA PHARMA AMERICA, INC.
Otc Medication2021-08-22
Merz Pharmaceuticals, LLC, Merz Pharma GmbH & Co. KGaA
Prescription Medication2021-04-28
Merz North America, Inc., Merz Pharma GmbH & Co. KGaA
Prescription Medication2021-04-28
Solstice Neurosciences, LLC, MDD US Operations, LLC, Catalent Pharma Solutions, LLC, Eurofins Lancaster Laboratories, Inc., IDT Biologica GmbH, Merz Pharma GmbH & Co. KGaA, Pacific BioLabs
Prescription Medication2021-03-24
Merz Pharmaceuticals, LLC, Merz Pharma GmbH & Co. KGaA
Prescription Medication2020-12-22
Merz North America, Inc., Merz Pharma GmbH & Co. KGaA
Prescription Medication2020-12-22
HRA PHARMA AMERICA, INC.
Otc Medication2020-11-24
HRA PHARMA AMERICA, INC.
Otc Medication2020-11-24
HRA PHARMA AMERICA, INC.
Otc Medication2020-11-24
HRA PHARMA AMERICA, INC.
Otc Medication2020-11-19
HRA Pharma America, Inc., Merz Pharma GmbH & Co KGaA
Otc Medication2020-11-19
HRA PHARMA AMERICA, INC.
Otc Medication2020-10-31
HRA Pharma America, Inc., Merz Pharma GmbH & Co KGaA
Otc Medication2020-10-31
HRA PHARMA AMERICA, INC.
Otc Medication2020-10-31
HRA PHARMA AMERICA, INC.
Otc Medication2020-10-31
HRA PHARMA AMERICA, INC.
Otc Medication2020-10-31
Merz Pharmaceuticals, LLC, Merz Pharma GmbH & Co. KGaA
Prescription Medication2020-10-29
Merz North America, Inc., Merz Pharma GmbH & Co. KGaA
Prescription Medication2020-10-29
Solstice Neurosciences, LLC, MDD US Operations, LLC, Catalent Pharma Solutions, LLC, Eurofins Lancaster Laboratories, Inc., IDT Biologica GmbH, Merz Pharma GmbH & Co. KGaA, Pacific BioLabs
Prescription Medication2020-10-23
Merz North America, Inc., Merz Pharma GmbH & Co. KGaA
Prescription Medication2020-09-03
Merz Pharmaceuticals, LLC, Merz Pharma GmbH & Co. KGaA
Prescription Medication2020-08-28
Solstice Neurosciences, LLC, MDD US Operations, LLC, Catalent Pharma Solutions, LLC, Eurofins Lancaster Laboratories, Inc., IDT Biologica GmbH, Merz Pharma GmbH & Co. KGaA, Pacific BioLabs
Prescription Medication2020-08-15
Solstice Neurosciences, LLC, MDD US Operations, LLC, Catalent Pharma Solutions, LLC, Eurofins Lancaster Laboratories, Inc., IDT Biologica GmbH, Merz Pharma GmbH & Co. KGaA, Pacific BioLabs
Prescription Medication2020-01-01
Merz North America, Inc., Merz Pharma GmbH & Co. KGaA
Prescription Medication2019-10-31
Solstice Neurosciences, LLC, MDD US Operations, LLC, Catalent Pharma Solutions, LLC, Eurofins Lancaster Laboratories, Inc., IDT Biologica GmbH, Merz Pharma GmbH & Co. KGaA, Pacific BioLabs
Prescription Medication2019-10-10
Solstice Neurosciences, LLC, MDD US Operations, LLC, Catalent Pharma Solutions, LLC, Eurofins Lancaster Laboratories, Inc., IDT Biologica GmbH, Merz Pharma GmbH & Co. KGaA, Pacific BioLabs
Prescription Medication2019-08-30
Solstice Neurosciences, LLC, MDD US Operations, LLC, Catalent Pharma Solutions, LLC, Eurofins Lancaster Laboratories, Inc., IDT Biologica GmbH, Merz Pharma GmbH & Co. KGaA, Pacific BioLabs
Prescription Medication2019-07-11
Merz North America, Inc., Merz Pharma GmbH & Co. KGaA
Prescription Medication2019-05-17
Merz Pharmaceuticals, LLC, Merz Pharma GmbH & Co. KGaA
Prescription Medication2019-05-14

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U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020072851992Anvers,Belgium -> New York/Newark Area, Newark, New JerseyXEOMIN VIAL / MEDICAL EQUIPMENT586 CTN
2020072851992Anvers,Belgium -> New York/Newark Area, Newark, New JerseyXEOMIN VIAL / MEDICAL EQUIPMENT586 CTN

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