Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
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 11 spellings of its name, each linked to the record. See the Amneal Pharmaceuticals group view.
As of Nov 14, 2026, FDA's public records list Amneal Pharmaceuticals and its 7 subsidiaries with 627 drug applications, 57 drug recalls, 3 complete response letters, 1 warning letter and 1 OPDP letter. The most recent is an OPDP letter dated Mar 31, 2026: Untitled letter: ALYMSYS.
Group recordsLabelled by a language model (which subsidiaries belong to the group) from the firm's FDA names. It is not an FDA field.: 689, 8 entities
Drug applications: 627
Drug recalls: 57
Complete response letters: 3
Warning letters: 1
Records by Year
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Amneal Pharmaceuticals and its 7 subsidiaries
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
462017Records46
6220182018Records62vs 2017+16
422019Records42vs 2018−20
3520202020Records35vs 2019−7
182021Records18vs 2020−17
3320222022Records33vs 2021+15
342023Records34vs 2022+1
3220242024Records32vs 2023−2
402025Records40vs 2024+8
1720262026 to dateRecords17
Latest Records
Newest first across sources; each opens the record
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