This page includes the latest FDA filings for Shire Us Manufacturing Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
Device Company | Device | Date |
|---|---|---|
| Shire US Manufacturing Inc. | Prescription Medication | 2024-01-31 |
| Takeda Pharmaceuticals America, Inc., Sterling Wisconsin, LLC, Catalent Pharma Solutions, LLC, Patheon Manufacturing Services LLC, Powdersize, LLC | Prescription Medication | 2023-12-30 |
| Shire US Manufacturing Inc., Patheon Manufacturing Services LLC, Corden Pharma Bergamo, S.p.A., Exova Inc., Reading Scientific Services Ltd (RSSL), SSCI Inc. (Aptuit), Microbac Laboratories, Inc., Catalent Germany Schorndorf GmbH, BCM Ltd, Reckitt Benckiser Healthc | Prescription Medication | 2023-12-22 |
| Takeda Pharmaceuticals America, Inc., Cosmo SpA, Sharp Corporation, PharmaZell GmbH, PharmaZell (India) Private Ltd. | Prescription Medication | 2023-11-22 |
| Shire US Manufacturing Inc., Sharp Packaging Systems, Inc, Sharp Packaging Systems, Inc., PharmaZell GmbH, Cosmo SpA, PharmaZell (Vizag) Private Ltd. | Prescription Medication | 2023-11-04 |
| Takeda Pharmaceuticals America, Inc., Patheon Manufacturing Services LLC, PharmaZell GmbH, Syntese A/S, Sharp Packaging Services, LLC | Prescription Medication | 2023-11-03 |
| Takeda Pharmaceuticals America, Inc., Cambrex Charles City, Inc, Patheon Manufacturing Services LLC | Prescription Medication | 2023-10-30 |
| Takeda Pharmaceuticals America, Inc., Cambrex Charles City, Inc, Patheon Manufacturing Services LLC, Unither Manufacturing LLC, Sharp Corporation | Prescription Medication | 2023-10-27 |
| Takeda Pharmaceuticals America, Inc., Patheon Manufacturing Services LLC, PharmaZell GmbH, Syntese A/S, Sharp Packaging Services, LLC | Prescription Medication | 2023-09-21 |
| Shire US Manufacturing Inc., Sharp Packaging Systems, Inc, Sharp Packaging Systems, Inc., PharmaZell GmbH, Cosmo SpA, PharmaZell (Vizag) Private Ltd. | Prescription Medication | 2023-09-21 |
| Shire US Manufacturing Inc., Patheon Manufacturing Services LLC, Corden Pharma Bergamo, S.p.A., Exova Inc., Reading Scientific Services Ltd (RSSL), SSCI Inc. (Aptuit), Microbac Laboratories, Inc., Catalent Germany Schorndorf GmbH, BCM Ltd, Reckitt Benckiser Healthc | Prescription Medication | 2023-05-25 |
| Takeda Pharmaceuticals America, Inc., Patheon Manufacturing Services LLC, Jubilant Life Sciences Limited | Prescription Medication | 2023-04-22 |
| Shire US Manufacturing Inc., Patheon Manufacturing Services LLC, Corden Pharma Bergamo, S.p.A., Exova Inc., Reading Scientific Services Ltd (RSSL), SSCI Inc. (Aptuit), Microbac Laboratories, Inc., Catalent Germany Schorndorf GmbH, BCM Ltd, Reckitt Benckiser Healthc | Prescription Medication | 2023-01-26 |
| Takeda Pharmaceuticals America, Inc., Sterling Wisconsin, LLC, Catalent Pharma Solutions, LLC, Patheon Manufacturing Services LLC, Powdersize, LLC | Prescription Medication | 2022-12-30 |
| Takeda Pharmaceuticals America, Inc., Industriale Chimica SRL, Catalent Pharma Solutions, LLC, Mayne Pharma International Pty Ltd., Patheon Manufacturing Services LLC, Quimica Sintetica S.A. | Prescription Medication | 2022-12-30 |
| Takeda Pharmaceuticals America, Inc., Patheon Manufacturing Services LLC, Jubilant Life Sciences Limited | Prescription Medication | 2022-12-23 |
| Takeda Pharmaceuticals America, Inc., Cosmo SpA, Sharp Corporation, PharmaZell GmbH, PharmaZell (India) Private Ltd. | Prescription Medication | 2022-12-23 |
| Takeda Pharmaceuticals America, Inc., Patheon Manufacturing Services LLC, PharmaZell GmbH, Syntese A/S, Sharp Packaging Services, LLC | Prescription Medication | 2022-11-24 |
| Shire US Manufacturing Inc., Sharp Packaging Systems, Inc, Sharp Packaging Systems, Inc., PharmaZell GmbH, Cosmo SpA, PharmaZell (Vizag) Private Ltd. | Prescription Medication | 2022-11-24 |
| Shire US Manufacturing Inc. | Prescription Medication | 2022-11-08 |
| Shire US Manufacturing Inc. | Prescription Medication | 2022-11-08 |
| Takeda Pharmaceuticals America, Inc. | Prescription Medication | 2022-11-08 |
| Takeda Pharmaceuticals America, Inc. | Prescription Medication | 2022-11-08 |
| Takeda Pharmaceuticals America, Inc., Cambrex Charles City, Inc, Patheon Manufacturing Services LLC | Prescription Medication | 2022-11-08 |
| Takeda Pharmaceuticals America, Inc., Cambrex Charles City, Inc, Patheon Manufacturing Services LLC, Unither Manufacturing LLC, Sharp Corporation | Prescription Medication | 2022-11-02 |
| Takeda Pharmaceuticals America, Inc. | Prescription Medication | 2022-09-22 |
| Takeda Pharmaceuticals America, Inc. | Prescription Medication | 2022-07-22 |
| Shire US Manufacturing Inc. | Prescription Medication | 2022-05-12 |
| Takeda Pharmaceuticals America, Inc., Patheon Manufacturing Services LLC, Jubilant Life Sciences Limited | Prescription Medication | 2022-04-02 |
| Takeda Pharmaceuticals America, Inc., Cambrex Charles City, Inc, Patheon Manufacturing Services LLC, Unither Manufacturing LLC, Sharp Corporation | Prescription Medication | 2022-03-10 |
| Takeda Pharmaceuticals America, Inc., Cambrex Charles City, Inc, Patheon Manufacturing Services LLC | Prescription Medication | 2022-03-05 |
| Takeda Pharmaceuticals America, Inc., Cambrex Charles City, Inc, Patheon Manufacturing Services LLC, Unither Manufacturing LLC, Sharp Corporation | Prescription Medication | 2022-01-15 |
| Takeda Pharmaceuticals America, Inc., Cosmo SpA, Sharp Corporation, PharmaZell GmbH, PharmaZell (India) Private Ltd. | Prescription Medication | 2022-01-05 |
| Takeda Pharmaceuticals America, Inc., Patheon Manufacturing Services LLC, Jubilant Life Sciences Limited | Prescription Medication | 2021-12-09 |
| Takeda Pharmaceuticals America, Inc., Patheon Manufacturing Services LLC, PharmaZell GmbH, Syntese A/S, Sharp Packaging Services, LLC | Prescription Medication | 2021-11-13 |
| Shire US Manufacturing Inc., Sharp Packaging Systems, Inc, Sharp Packaging Systems, Inc., PharmaZell GmbH, Cosmo SpA, PharmaZell (Vizag) Private Ltd. | Prescription Medication | 2021-11-13 |
| Takeda Pharmaceuticals America, Inc., Sterling Wisconsin, LLC, Catalent Pharma Solutions, LLC, Patheon Manufacturing Services LLC, Powdersize, LLC | Prescription Medication | 2021-10-28 |
| Takeda Pharmaceuticals America, Inc. | Prescription Medication | 2021-10-09 |
| Shire US Manufacturing Inc. | Prescription Medication | 2021-10-08 |
| Takeda Pharmaceuticals America, Inc., The Ritedose Corporation, Cambrex Charles City, Inc, AMRI Rensselaer, Inc., SGS Life Science Services, Albany Molecular Research, Inc., ACM PHARMA, PPD Development, L.P., Sharp Corporation, Laboratoire Unither | Prescription Medication | 2021-10-07 |
| Takeda Pharmaceuticals America, Inc., Cosmo SpA, Sharp Corporation, PharmaZell GmbH, PharmaZell (India) Private Ltd. | Prescription Medication | 2021-07-31 |
| Takeda Pharmaceuticals America, Inc., Sterling Wisconsin, LLC, Catalent Pharma Solutions, LLC, Patheon Manufacturing Services LLC, Powdersize, LLC | Prescription Medication | 2021-07-24 |
| Takeda Pharmaceuticals America, Inc., Cosmo SpA, Sharp Corporation, PharmaZell GmbH, PharmaZell (India) Private Ltd. | Prescription Medication | 2021-07-22 |
| Shire US Manufacturing Inc., Sharp Packaging Systems, Inc, Sharp Packaging Systems, Inc., PharmaZell GmbH, Cosmo SpA, PharmaZell (Vizag) Private Ltd. | Prescription Medication | 2021-07-22 |
| Takeda Pharmaceuticals America, Inc., Patheon Manufacturing Services LLC, PharmaZell GmbH, Syntese A/S, Sharp Packaging Services, LLC | Prescription Medication | 2021-06-11 |
| Takeda Pharmaceuticals America, Inc. | Prescription Medication | 2021-06-05 |
| Takeda Pharmaceuticals America, Inc. | Prescription Medication | 2021-03-26 |
| Shire US Manufacturing Inc., Sharp Packaging Systems, Inc, Sharp Packaging Systems, Inc., PharmaZell GmbH, Cosmo SpA, PharmaZell (Vizag) Private Ltd. | Prescription Medication | 2021-02-27 |
| Takeda Pharmaceuticals America, Inc., Patheon Manufacturing Services LLC, PharmaZell GmbH, Syntese A/S, Sharp Packaging Services, LLC | Prescription Medication | 2021-02-12 |
| Takeda Pharmaceuticals America, Inc., Industriale Chimica SRL, Catalent Pharma Solutions, LLC, Mayne Pharma International Pty Ltd., Patheon Manufacturing Services LLC, Quimica Sintetica S.A. | Prescription Medication | 2021-02-05 |
| Shire US Manufacturing Inc., Patheon Manufacturing Services LLC, Corden Pharma Bergamo, S.p.A., Exova Inc., Reading Scientific Services Ltd (RSSL), SSCI Inc. (Aptuit), Microbac Laboratories, Inc., Catalent Germany Schorndorf GmbH, BCM Ltd, Reckitt Benckiser Healthc | Prescription Medication | 2021-01-24 |
| Takeda Pharmaceuticals America, Inc., Cambrex Charles City, Inc, Patheon Manufacturing Services LLC | Prescription Medication | 2021-01-13 |
| Takeda Pharmaceuticals America, Inc. | Prescription Medication | 2021-01-12 |
| Shire US Manufacturing Inc., Sharp Packaging Systems, Inc, Sharp Packaging Systems, Inc., PharmaZell GmbH, Cosmo SpA, PharmaZell (Vizag) Private Ltd. | Prescription Medication | 2020-12-29 |
| Shire US Manufacturing Inc. | Prescription Medication | 2020-12-24 |
| Takeda Pharmaceuticals America, Inc., Cambrex Charles City, Inc, Patheon Manufacturing Services LLC, Unither Manufacturing LLC, Sharp Corporation | Prescription Medication | 2020-12-12 |
| Takeda Pharmaceuticals America, Inc., Sterling Wisconsin, LLC, Catalent Pharma Solutions, LLC, Patheon Manufacturing Services LLC, Powdersize, LLC | Prescription Medication | 2020-12-11 |
| Takeda Pharmaceuticals America, Inc., Patheon Manufacturing Services LLC, Jubilant Life Sciences Limited | Prescription Medication | 2020-11-26 |
| Shire US Manufacturing Inc. | Prescription Medication | 2020-11-25 |
| Takeda Pharmaceuticals America, Inc. | Prescription Medication | 2020-11-21 |
| Takeda Pharmaceuticals America, Inc., Patheon Manufacturing Services LLC, PharmaZell GmbH, Syntese A/S, Sharp Packaging Services, LLC | Prescription Medication | 2020-11-06 |
| Shire US Manufacturing Inc. | Prescription Medication | 2020-10-16 |
| Shire US Manufacturing Inc., Sharp Packaging Systems, Inc, Sharp Packaging Systems, Inc., PharmaZell GmbH, Cosmo SpA, PharmaZell (Vizag) Private Ltd. | Prescription Medication | 2020-10-16 |
| Takeda Pharmaceuticals America, Inc., Patheon Manufacturing Services LLC, PharmaZell GmbH, Syntese A/S, Sharp Packaging Services, LLC | Prescription Medication | 2020-10-15 |
| Shire US Manufacturing Inc. | Prescription Medication | 2020-09-15 |
| Takeda Pharmaceuticals America, Inc. | Prescription Medication | 2020-08-22 |
| Shire US Manufacturing Inc., Sharp Packaging Systems, Inc, Sharp Packaging Systems, Inc., PharmaZell GmbH, Cosmo SpA, PharmaZell (Vizag) Private Ltd. | Prescription Medication | 2020-07-03 |
| Shire US Manufacturing Inc. | Prescription Medication | 2020-06-20 |
| Shire US Manufacturing Inc., Patheon Manufacturing Services LLC, Corden Pharma Bergamo, S.p.A., Exova Inc., Reading Scientific Services Ltd (RSSL), SSCI Inc. (Aptuit), Microbac Laboratories, Inc., Catalent Germany Schorndorf GmbH, BCM Ltd, Reckitt Benckiser Healthc | Prescription Medication | 2020-06-04 |
| Shire US Manufacturing Inc. | Prescription Medication | 2020-05-01 |
| Takeda Pharmaceuticals America, Inc., Cambrex Charles City, Inc, Patheon Manufacturing Services LLC | Prescription Medication | 2020-04-01 |
| Takeda Pharmaceuticals America, Inc., Sterling Wisconsin, LLC, Catalent Pharma Solutions, LLC, Patheon Manufacturing Services LLC, Powdersize, LLC | Prescription Medication | 2020-03-11 |
| Takeda Pharmaceuticals America, Inc., The Ritedose Corporation, Cambrex Charles City, Inc, AMRI Rensselaer, Inc., SGS Life Science Services, Albany Molecular Research, Inc., ACM PHARMA, PPD Development, L.P., Sharp Corporation, Laboratoire Unither | Prescription Medication | 2020-03-05 |
| Takeda Pharmaceuticals America, Inc., Industriale Chimica SRL, Catalent Pharma Solutions, LLC, Mayne Pharma International Pty Ltd., Patheon Manufacturing Services LLC, Quimica Sintetica S.A. | Prescription Medication | 2020-02-08 |
| Shire US Manufacturing Inc. | Prescription Medication | 2019-12-19 |
| Takeda Pharmaceuticals America, Inc. | Prescription Medication | 2019-12-10 |
| Shire US Manufacturing Inc., Patheon Manufacturing Services LLC, Corden Pharma Bergamo, S.p.A., Exova Inc., Reading Scientific Services Ltd (RSSL), SSCI Inc. (Aptuit), Microbac Laboratories, Inc., Catalent Germany Schorndorf GmbH, BCM Ltd, Reckitt Benckiser Healthc | Prescription Medication | 2019-12-06 |
| Shire US Manufacturing Inc. | Prescription Medication | 2019-11-20 |
| Takeda Pharmaceuticals America, Inc., The Ritedose Corporation, Cambrex Charles City, Inc, AMRI Rensselaer, Inc., SGS Life Science Services, Albany Molecular Research, Inc., ACM PHARMA, PPD Development, L.P., Sharp Corporation, Laboratoire Unither | Prescription Medication | 2019-11-16 |
| Takeda Pharmaceuticals America, Inc., Cosmo SpA, Sharp Corporation, PharmaZell GmbH, PharmaZell (India) Private Ltd. | Prescription Medication | 2019-10-26 |
| Takeda Pharmaceuticals America, Inc., Cambrex Charles City, Inc, Patheon Manufacturing Services LLC | Prescription Medication | 2019-10-16 |
| Shire US Manufacturing Inc. | Prescription Medication | 2019-08-13 |
| Takeda Pharmaceuticals America, Inc., Patheon Manufacturing Services LLC, PharmaZell GmbH, Syntese A/S, Sharp Packaging Services, LLC | Prescription Medication | 2019-07-31 |
| Shire US Manufacturing Inc., Sharp Packaging Systems, Inc, Sharp Packaging Systems, Inc., PharmaZell GmbH, Cosmo SpA, PharmaZell (Vizag) Private Ltd. | Prescription Medication | 2019-07-31 |
| Shire US Manufacturing Inc. | Firazyr | 2019-07-30 |
| Takeda Pharmaceuticals America, Inc. | Prescription Medication | 2019-07-30 |
| Takeda Pharmaceuticals America, Inc., Cambrex Charles City, Inc, Patheon Manufacturing Services LLC, Unither Manufacturing LLC, Sharp Corporation | Prescription Medication | 2019-07-18 |
| Takeda Pharmaceuticals America, Inc., Industriale Chimica SRL, Catalent Pharma Solutions, LLC, Mayne Pharma International Pty Ltd., Patheon Manufacturing Services LLC, Quimica Sintetica S.A. | Prescription Medication | 2019-05-18 |
| Takeda Pharmaceuticals America, Inc., Sterling Wisconsin, LLC, Catalent Pharma Solutions, LLC, Patheon Manufacturing Services LLC, Powdersize, LLC | Prescription Medication | 2019-01-03 |
| Takeda Pharmaceuticals America, Inc. | Prescription Medication | 2018-12-29 |
| Shire US Manufacturing Inc. | MOTEGRITY | 2018-12-14 |
| Shire US Manufacturing Inc. | MOTEGRITY | 2018-12-14 |
| Shire US Manufacturing Inc., Patheon Manufacturing Services LLC, Corden Pharma Bergamo, S.p.A., Exova Inc., Reading Scientific Services Ltd (RSSL), SSCI Inc. (Aptuit), Microbac Laboratories, Inc., Catalent Germany Schorndorf GmbH, BCM Ltd, Reckitt Benckiser Healthc | Prescription Medication | 2018-11-29 |
| Takeda Pharmaceuticals America, Inc. | Prescription Medication | 2018-11-28 |
| Takeda Pharmaceuticals America, Inc., Patheon Manufacturing Services LLC, Jubilant Life Sciences Limited | Prescription Medication | 2018-09-11 |
| Takeda Pharmaceuticals America, Inc., The Ritedose Corporation, Cambrex Charles City, Inc, AMRI Rensselaer, Inc., SGS Life Science Services, Albany Molecular Research, Inc., ACM PHARMA, PPD Development, L.P., Sharp Corporation, Laboratoire Unither | Prescription Medication | 2018-01-20 |
| Shire US Manufacturing Inc. | Prescription Medication | 2017-11-27 |
| Shire US Manufacturing Inc. | Mesalamine | 2017-08-29 |
| Shire US Manufacturing Inc. | MYDAYIS | 2017-06-20 |
| Shire US Manufacturing Inc. | MYDAYIS | 2017-06-20 |
| Shire US Manufacturing Inc. | MYDAYIS | 2017-06-20 |
| Shire US Manufacturing Inc. | MYDAYIS | 2017-06-20 |
| Shire US Manufacturing Inc. | Xiidra | 2016-07-11 |
| Shire US Manufacturing Inc. | Fosrenol | 2014-09-24 |
| Shire US Manufacturing Inc. | Fosrenol | 2014-09-24 |
| Shire US Manufacturing Inc. | Firazyr | 2011-08-25 |
| Shire US Manufacturing Inc. | VPRIV | 2010-02-26 |
| Shire US Manufacturing Inc. | Intuniv | 2009-09-02 |
| Shire US Manufacturing Inc. | Intuniv | 2009-09-02 |
| Shire US Manufacturing Inc. | Intuniv | 2009-09-02 |
| Shire US Manufacturing Inc. | Intuniv | 2009-09-02 |
| Shire US Manufacturing Inc. | Intuniv | 2009-09-02 |
| Shire US Manufacturing Inc. | Lialda | 2007-01-16 |
| Shire US Manufacturing Inc. | ELAPRASE | 2006-07-24 |
| Shire US Manufacturing Inc. | Fosrenol | 2005-11-23 |
| Shire US Manufacturing Inc. | Fosrenol | 2005-11-23 |
| Shire US Manufacturing Inc. | Fosrenol | 2004-10-26 |
| Shire US Manufacturing Inc. | Pentasa | 2004-07-08 |
| Shire US Manufacturing Inc. | Adderall | 2002-05-22 |
| Shire US Manufacturing Inc. | Adderall | 2002-05-22 |
| Shire US Manufacturing Inc. | Adderall | 2002-05-22 |
| Shire US Manufacturing Inc. | Adderall | 2001-10-11 |
| Shire US Manufacturing Inc. | Adderall | 2001-10-11 |
| Shire US Manufacturing Inc. | Adderall | 2001-10-11 |
| Shire US Manufacturing Inc. | Carbatrol | 1999-12-22 |
| Shire US Manufacturing Inc. | Carbatrol | 1997-09-30 |
| Shire US Manufacturing Inc. | Carbatrol | 1997-09-30 |
| Shire US Manufacturing Inc. | Agrylin | 1997-03-14 |
| Shire US Manufacturing Inc. | Pentasa | 1993-05-10 |
| Import ID | Shipment | Cargo Description | Quantity |
|---|---|---|---|
| 20181221256 | Bremerhaven,Federal Republic of Germany -> Norfolk, Virginia | PHARMACEUTICAL PRODUCTS HS: 292250 | 64 PCS |
| 201810317976 | Bremerhaven,Federal Republic of Germany -> Norfolk, Virginia | PHARMACEUTICAL PRODUCTS HS: 292250 | 80 PCS |
| 201810269827 | Bremerhaven,Federal Republic of Germany -> Norfolk, Virginia | PHARMACEUTICAL PRODUCTS HS: 292250 | 80 PCS |
| 2018102414015 | Bremerhaven,Federal Republic of Germany -> Norfolk, Virginia | PHARMACEUTICAL PRODUCTS HS: 292250 | 80 PCS |
| 201810131119 | Bremerhaven,Federal Republic of Germany -> Norfolk, Virginia | MESALAMINE HS:292250 | 80 PCS |
| 2018101314881 | Rotterdam,Netherlands -> Norfolk, Virginia | PHARMACEUTICAL PRODUCTS HS: 292250 | 64 PCS |
| 2018101213705 | Rotterdam,Netherlands -> Norfolk, Virginia | PHARMACEUTICAL PRODUCTS HS: 292250 | 64 PCS |
| 2018100332433 | Rotterdam,Netherlands -> Norfolk, Virginia | PHARMACEUTICAL PRODUCTS HS: 292250 | 64 PCS |