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.. FDA records under 4 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Amphastar Pharmaceuticals and its 3 subsidiaries with 76 drug applications, 5 510(k) clearances, 3 complete response letters, 2 drug recalls and 1 warning letter. The most recent is a warning letter dated Jul 2, 2026: Warning letter: Aseptic processing, Sterility assurance, Environmental monitoring.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Amphastar Pharmaceuticals and its 3 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jul 2, 2026 | Warning letter: Aseptic processing, Sterility assurance, Environmental monitoringCDER | Warning letters |
| Apr 1, 2026 | EPINEPHRINE Injection, USP, 1 mg/10mL (0.1 mg/mL), Rx only, INTERNATIONAL MEDICATION SYSTEMS, LIMITED, So. EL Monte, CA 91733, An Amphastar Class II · Lack of Assurance of Sterility | Drug recalls |
| Feb 26, 2026 | Complete response letter, BLA 761403Unapproved | Complete response letters |
| Feb 12, 2021 | Surgical Face MaskK201545 · FXX | 510(k) clearances |
| Dec 12, 2018 | Complete response letter, NDA 211363Approved | Complete response letters |
| Feb 17, 2017 | Complete response letter, NDA 208969Approved | Complete response letters |
| May 19, 1995 | STERILE EMPTY PCA SYRINGEK945797 · FMF | 510(k) clearances |
| Jun 11, 1987 | QUIK-BRUSHK870414 · EFW | 510(k) clearances |
| Mar 18, 1986 | UNICADDY I & II I.V. CONTAINER CADDY IMS POLE MATEK860468 · FOX | 510(k) clearances |
| Dec 17, 1985 | THE CALIFORNIA SPLINTK854752 · DXQ | 510(k) clearances |
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
