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.
| Registration Number | 3006999111 |
| FEI Number | 3006999111 |
| Name | MERZ PHARMA GMBH & CO. KGAA |
| Owner & Operator | Merz Pharma GmbH & Co. KGaA |
| Contact Address | Ludwigstrasse 22 Reinheim DE-NOTA 64354 DE |
| Official Correspondent |
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| US Agent |
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| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | Ludwigstrasse 22 Reinheim Hessen, 64354 DE |
| Establishment Type | Manufacture Medical Device for Another Party (Contract Manufacturer) |
Device Company | Device | Date |
|---|---|---|
| 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 Medication | 2025-08-17 |
| HRA PHARMA AMERICA, INC. | Otc Medication | 2025-01-29 |
| HRA PHARMA AMERICA, INC. | Otc Medication | 2025-01-29 |
| HRA PHARMA AMERICA, INC. | Otc Medication | 2025-01-29 |
| HRA PHARMA AMERICA, INC. | Otc Medication | 2025-01-29 |
| HRA PHARMA AMERICA, INC. | Otc Medication | 2025-01-27 |
| Merz Pharmaceuticals, LLC, Merz Pharma GmbH & Co. KGaA | Prescription Medication | 2024-12-22 |
| Merz North America, Inc., Merz Pharma GmbH & Co. KGaA | Prescription Medication | 2024-12-22 |
| 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 Medication | 2024-10-13 |
| Merz Pharmaceuticals, LLC, Merz Pharma GmbH & Co. KGaA | Prescription Medication | 2024-08-22 |
| Merz North America, Inc., Merz Pharma GmbH & Co. KGaA | Prescription Medication | 2024-08-22 |
| Merz Pharmaceuticals, LLC, Merz Pharma GmbH & Co. KGaA | Prescription Medication | 2024-07-23 |
| Merz North America, Inc., Merz Pharma GmbH & Co. KGaA | Prescription Medication | 2024-07-23 |
| Pharma Packaging Solutions, LLC dba Tjoapack LLC, Merz Pharma GmbH & Co. KGaA | Otc Medication | 2024-03-16 |
| 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 Medication | 2023-12-21 |
| HRA PHARMA AMERICA, INC. | Otc Medication | 2023-12-01 |
| HRA PHARMA AMERICA, INC. | Otc Medication | 2023-11-07 |
| HRA PHARMA AMERICA, INC. | Otc Medication | 2023-11-07 |
| HRA PHARMA AMERICA, INC. | Otc Medication | 2023-11-04 |
| HRA PHARMA AMERICA, INC. | Otc Medication | 2023-11-03 |
| Merz Pharmaceuticals, LLC, Merz Pharma GmbH & Co. KGaA | Prescription Medication | 2023-09-23 |
| Merz North America, Inc., Merz Pharma GmbH & Co. KGaA | Prescription Medication | 2023-09-20 |
| HRA Pharma America, Inc., Merz Pharma GmbH & Co KGaA | Otc Medication | 2022-10-29 |
| 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 Medication | 2022-10-15 |
| Merz Pharmaceuticals, LLC, Merz Pharma GmbH & Co. KGaA | Prescription Medication | 2022-09-13 |
| Merz North America, Inc., Merz Pharma GmbH & Co. KGaA | Prescription Medication | 2022-09-13 |
| 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 Medication | 2022-06-26 |
| HRA PHARMA AMERICA, INC. | Otc Medication | 2022-03-09 |
| Merz Pharmaceuticals, LLC, Merz Pharma GmbH & Co. KGaA | Prescription Medication | 2021-08-26 |
| Merz North America, Inc., Merz Pharma GmbH & Co. KGaA | Prescription Medication | 2021-08-26 |
| HRA PHARMA AMERICA, INC. | Otc Medication | 2021-08-22 |
| Merz Pharmaceuticals, LLC, Merz Pharma GmbH & Co. KGaA | Prescription Medication | 2021-04-28 |
| Merz North America, Inc., Merz Pharma GmbH & Co. KGaA | Prescription Medication | 2021-04-28 |
| 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 Medication | 2021-03-24 |
| Merz Pharmaceuticals, LLC, Merz Pharma GmbH & Co. KGaA | Prescription Medication | 2020-12-22 |
| Merz North America, Inc., Merz Pharma GmbH & Co. KGaA | Prescription Medication | 2020-12-22 |
| HRA PHARMA AMERICA, INC. | Otc Medication | 2020-11-24 |
| HRA PHARMA AMERICA, INC. | Otc Medication | 2020-11-24 |
| HRA PHARMA AMERICA, INC. | Otc Medication | 2020-11-24 |
| HRA PHARMA AMERICA, INC. | Otc Medication | 2020-11-19 |
| HRA Pharma America, Inc., Merz Pharma GmbH & Co KGaA | Otc Medication | 2020-11-19 |
| HRA PHARMA AMERICA, INC. | Otc Medication | 2020-10-31 |
| HRA Pharma America, Inc., Merz Pharma GmbH & Co KGaA | Otc Medication | 2020-10-31 |
| HRA PHARMA AMERICA, INC. | Otc Medication | 2020-10-31 |
| HRA PHARMA AMERICA, INC. | Otc Medication | 2020-10-31 |
| HRA PHARMA AMERICA, INC. | Otc Medication | 2020-10-31 |
| Merz Pharmaceuticals, LLC, Merz Pharma GmbH & Co. KGaA | Prescription Medication | 2020-10-29 |
| Merz North America, Inc., Merz Pharma GmbH & Co. KGaA | Prescription Medication | 2020-10-29 |
| 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 Medication | 2020-10-23 |
| Merz North America, Inc., Merz Pharma GmbH & Co. KGaA | Prescription Medication | 2020-09-03 |
| Merz Pharmaceuticals, LLC, Merz Pharma GmbH & Co. KGaA | Prescription Medication | 2020-08-28 |
| 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 Medication | 2020-08-15 |
| 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 Medication | 2020-01-01 |
| Merz North America, Inc., Merz Pharma GmbH & Co. KGaA | Prescription Medication | 2019-10-31 |
| 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 Medication | 2019-10-10 |
| 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 Medication | 2019-08-30 |
| 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 Medication | 2019-07-11 |
| Merz North America, Inc., Merz Pharma GmbH & Co. KGaA | Prescription Medication | 2019-05-17 |
| Merz Pharmaceuticals, LLC, Merz Pharma GmbH & Co. KGaA | Prescription Medication | 2019-05-14 |
| NCAGE Code | CD937 | MERZ PHARMA GMBH & CO. KGAA |
| CAGE Code | CD937 | MERZ PHARMA GMBH & CO. KGAA |
| Import ID | Shipment | Cargo Description | Quantity |
|---|---|---|---|
| 2020072851992 | Anvers,Belgium -> New York/Newark Area, Newark, New Jersey | XEOMIN VIAL / MEDICAL EQUIPMENT | 586 CTN |
| 2020072851992 | Anvers,Belgium -> New York/Newark Area, Newark, New Jersey | XEOMIN VIAL / MEDICAL EQUIPMENT | 586 CTN |