Pharmaceutical companyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in JapanLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record. See the Astellas group view.
As of Nov 13, 2026, FDA's public records list Astellas Pharma and its 4 subsidiaries with 44 drug applications, 5 drug recalls and 3 complete response letters. The most recent is a drug recall dated Dec 23, 2024: Prograf (tacrolimus) capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Product of Japan,….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Astellas Pharma and its 4 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Dec 23, 2024 | Prograf (tacrolimus) capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Product of Japan, Distributed by: Astellas Pharma US, Inc., NorthbrooClass I · Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules | Drug recalls |
| Dec 23, 2024 | Astagraf XL (tacrolimus extended-release capsules) 0.5 mg, 30-count bottles, RX Only, Product of Japan, Distributed by: Astellas Pharma US IClass I · Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules | Drug recalls |
| Nov 15, 2024 | Complete response letter, NDA 217225/S-001Approved | Complete response letters |
| Jan 4, 2024 | Complete response letter, BLA 761365Approved | Complete response letters |
| Aug 28, 2017 | Complete response letter, NDA 209529Approved | Complete response letters |
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
