Generic drug makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United KingdomLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Hikma Pharmaceuticals and its 9 subsidiaries with 748 drug applications, 71 drug recalls and 4 complete response letters. The most recent is a complete response letter dated Dec 23, 2024: Complete response letter, NDA 219357.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Hikma Pharmaceuticals and its 9 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Dec 23, 2024 | Complete response letter, NDA 219357Unapproved | Complete response letters |
| Oct 21, 2024 | Complete response letter, NDA 219045Unapproved | Complete response letters |
| Jan 23, 2024 | Complete response letter, NDA 218258Unapproved | Complete response letters |
| Feb 28, 2020 | Complete response letter, NDA 212045Approved | Complete response letters |
| Apr 4, 2017 | Doxercalciferol Capsules 0.5mcg, 50 count bottles, Rx, only, Manufactured by Cipla Limited Kurkumbh, Maharashtra, India, Manufactured for WeClass III · Failed Tablet/Capsule Specifications; during an internal inspection, capsules were found with illegible print. | Drug recalls |
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
