Generic drug makerLabelled 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., part of Teva. FDA records under 7 spellings of its name, each linked to the record. See the Teva group view.
As of Nov 14, 2026, FDA's public records list Teva Pharmaceuticals with 161 drug applications, 2 complete response letters and 1 drug recall. The most recent is a complete response letter dated Jul 30, 2025: Complete response letter, BLA 761385.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jul 30, 2025 | Complete response letter, BLA 761385Unapproved | Complete response letters |
| May 31, 2017 | Paliperidone Extended-Release Tablets, 3 mg, 90 count bottles, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL Class I · Failed Dissolution Specifications: Drug release test result, obtained during routine 9-month stability testing, which wa | Drug recalls |
| May 27, 2016 | Complete response letter, NDA 208082Approved | 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
