Takeda Pharmaceuticals USA
Pharmaceutical companyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 6 spellings of its name, each linked to the record. See the Takeda group view.
- Group recordsLabelled by a language model (which subsidiaries belong to the group) from the firm's FDA names. It is not an FDA field.: 115, 18 entities
- Drug applications: 82
- 510(k) clearances: 14
- Drug recalls: 12
- OPDP letters: 3
Records by Year
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Takeda Pharmaceuticals USA and its 17 subsidiaries
Latest Records
Newest first across sources; each opens the record| Date | Record | Source |
|---|---|---|
| Sep 9, 2025 | Untitled letter: ICLUSIGOffice of Prescription Drug Promotion | OPDP letters |
| Sep 9, 2025 | Untitled letter: FRUZAQLAOffice of Prescription Drug Promotion | OPDP letters |
| Sep 9, 2025 | Untitled letter: FRUZAQLAOffice of Prescription Drug Promotion | OPDP letters |
| Jul 18, 2025 | HyHub™ and HyHub™ Duo Vial Access DevicesK243404 · LHI | 510(k) clearances |
| Dec 17, 2021 | Complete response letter, NDA 213976Approved | Complete response letters |
| Oct 13, 2021 | Warning letter: DrugsCDER | Warning letters |
| Jun 9, 2020 | Warning letter: Aseptic processing, Sterility assurance, Environmental monitoringCDER | Warning letters |
| Dec 17, 2019 | Complete response letter, BLA 761133Approved | Complete response letters |
| May 21, 2015 | CONTRAVE (naltrexone HCl and bupropion HCl )extended-release tablets, 8 mg/ 90 mg, 120-count bottle, Rx only, Manufactured for Orexigen TherClass II · Failed Tablet/Capsule Specifications: Potential tablet defect of broken tablets and/or equatorial splitting of the bilay | Drug recalls |
| Jan 7, 2002 | CISTEM FLUID TRANSFER DEVICE, MODEL 7S2012 AND 7S2013K013523 · LHI | 510(k) clearances |
| Feb 12, 1993 | NYCOPLASTINK920767 · GJS | 510(k) clearances |
| May 9, 1986 | TAKEDA MEDICAL DIGITAL SPHYGMOMANOMETER, UA-731K854797 · DXN | 510(k) clearances |
| Nov 14, 1985 | DIGITAL SPHYGMOMANOMETER MODEL 7620K853158 · DXN | 510(k) clearances |
| Sep 9, 1985 | COPAL DIGITAL SPHYGMOMANOMETER UA-560K851223 · DXN | 510(k) clearances |
| Aug 19, 1985 | COPAL UA-512 DIGITAL BLOOD PRESSURE MONITORK852564 · DXN | 510(k) clearances |
| May 15, 1985 | COPAL DIGITAL SPHYGMOMANOMETER UA-535K843390 · DXN | 510(k) clearances |
Subsidiaries and Divisions
17 firms in the Takeda Pharmaceuticals USA group, most records first- Shire20 records
- Takeda Medical11 records
- Shire Richwood8 records
- Shire Human Genetic Therapies5 records
- New River Pharmaceuticals3 records
- Takeda Pharmaceuticals3 records
- Takeda Pharmaceuticals North America3 records
- Dyax2 records
- Takeda Development Center Americas2 records
- Millennium Pharmaceuticals Inc.1 record
- NPS Pharmaceuticals1 record
- Nycomed Pharma1 record
- Nycomed US1 record
- Shire Biologics1 record
- Shire Human Genetic1 record
- Takeda Pharmaceuticals North America, Inc.1 record
- Takeda Pharmaceuticals America1 record
Canada and Imports
Across the Takeda Pharmaceuticals USA group, matched by company nameNames and Identifiers
- Appears as
- FEI numbers in warning letters
- Website
- takeda.com
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built