This page includes the latest FDA filings for Shire Human Genetic Therapies Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 3012962138 |
| FEI Number | 3012962138 |
| Name | SHIRE HUMAN GENETIC THERAPIES, INC. |
| Owner & Operator | Shire Human Genetic Therapies, Inc. |
| Contact Address | 1445 Lawrence Drive Thousand Oaks CA 91320 US |
| Official Correspondent |
|
| Registration Status | 1 |
| Initial Importer | Y |
| Registration Expiration | 2020-04-25 |
| Registration Address | 730 Stockton Drive Exton, PA 19341 US |
| Establishment Type | Complaint File Establishment per 21 CFR 820.198 |
| Registration Number | 3015054258 |
| FEI Number | 3015054258 |
| Name | SHIRE HUMAN GENETIC THERAPIES, INC. |
| Owner & Operator | Shire Human Genetic Therapies, Inc. |
| Contact Address | 1445 Lawrence Drive Thousand Oaks CA 91320 US |
| Official Correspondent |
|
| Registration Status | 1 |
| Initial Importer | Y |
| Registration Expiration | 2020-04-25 |
| Registration Address | 1445 Lawrence Drive Thousand Oaks, CA 91320 US |
| Establishment Type | Complaint File Establishment per 21 CFR 820.198 |
| Registration Number | 3009340644 |
| FEI Number | 3009340644 |
| Name | SHIRE HUMAN GENETIC THERAPIES, INC. |
| Owner & Operator | Shire Human Genetic Therapies, Inc. |
| Contact Address | 1445 Lawrence Drive Thousand Oaks CA 91320 US |
| Official Correspondent |
|
| Registration Status | 1 |
| Initial Importer | Y |
| Registration Expiration | 2020-04-25 |
| Registration Address | 300 SHIRE WAY Lexington, MA 02421 US |
| Establishment Type |
|
Device Company | Device | Date |
|---|---|---|
| TAKEDA PHARMACEUTICALS AMERICA, INC., Takeda Manufacturing Singapore Pte Ltd, Takeda Manufacturing Austria AG, SGS Lab Simon, BioReliance Ltd, Sigma-Aldrich Pte Ltd, Shire Human Genetic Therapies Inc., Charles River Laboratories Germany GmbH, OFI Technologie & Inn | Prescription Medication | 2023-11-23 |
| Shire Human Genetic Therapies, Inc. | BAXJECT II Hi-Flow 3400691 | 2023-10-12 |
| SHIRE HUMAN GENETIC THERAPIES, INC. | Anti-Drug Antibody Biomarker Specimen Collection Kit: Gaucher and Hunter Patient | 2021-04-07 |
SHIRE HUMAN GENETIC THERAPIES, INC. | Anti-Drug Antibody Biomarker Specimen Collection Kit: Gaucher and Hunter Patients | 2019-08-26 |
SHIRE HUMAN GENETIC THERAPIES, INC. | Anti-Drug Antibody Biomarker Specimen Collection Kit: Gaucher and Hunter Patients | 2019-08-26 |
SHIRE HUMAN GENETIC THERAPIES, INC. | Natpara Mixing Device | 2018-11-12 |
SHIRE HUMAN GENETIC THERAPIES, INC. | Natpara Mixing Device | 2018-11-12 |
SHIRE HUMAN GENETIC THERAPIES, INC. | FlowEase Subcutaneous Infusion Set | 2018-11-05 |
SHIRE HUMAN GENETIC THERAPIES, INC. | FlowEase Subcutaneous Infusion Set | 2018-11-05 |
SHIRE HUMAN GENETIC THERAPIES, INC. | Baxject II Hi-Flow Needleless Transfer Device | 2018-11-05 |
SHIRE HUMAN GENETIC THERAPIES, INC. | Baxject II Hi-Flow Needleless Transfer Device | 2018-11-05 |
SHIRE HUMAN GENETIC THERAPIES, INC. | Baxject II Needleless Transfer Device | 2018-11-05 |
SHIRE HUMAN GENETIC THERAPIES, INC. | Baxject II Needleless Transfer Device | 2018-11-05 |
SHIRE HUMAN GENETIC THERAPIES, INC. | Syringe Stabilizer | 2018-11-05 |
SHIRE HUMAN GENETIC THERAPIES, INC. | Syringe Stabilizer | 2018-11-05 |
SHIRE HUMAN GENETIC THERAPIES, INC. | Q-cliq Pen | 2018-06-22 |
SHIRE HUMAN GENETIC THERAPIES, INC. | Cinryze | 2018-01-19 |
SHIRE HUMAN GENETIC THERAPIES, INC. | Cinryze | 2018-01-19 |
SHIRE HUMAN GENETIC THERAPIES, INC. | Q-cliq Pen | 2016-03-18 |
SHIRE HUMAN GENETIC THERAPIES, INC. | Q-cliq Pen | 2016-03-18 |
SHIRE HUMAN GENETIC THERAPIES, INC. | Gattex | 2016-03-18 |
SHIRE HUMAN GENETIC THERAPIES, INC. | Gattex | 2016-03-18 |
SHIRE HUMAN GENETIC THERAPIES, INC. | Firazyr | 2016-03-18 |
SHIRE HUMAN GENETIC THERAPIES, INC. | Firazyr | 2016-03-18 |
| SEC | 0001745009 | Shire Human Genetic Therapies, Inc. of DELAWARE |