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 Alembic PharmaceuticalsLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Alembic, LLC with 214 drug applications and 13 510(k) clearances. The most recent is a 510(k) clearance dated Oct 6, 2026: APRO 88 Catheter.
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.
| Date | Record | Source |
|---|---|---|
| Oct 6, 2026 | APRO 88 CatheterK261938 · QJP | 510(k) clearances |
| Aug 12, 2026 | APRO 35 Swift Catheter and Alembic Aspiration TubingK262391 · NRY | 510(k) clearances |
| Aug 12, 2026 | APRO 35 Swift CatheterK262392 · DQY | 510(k) clearances |
| May 1, 2025 | APRO 45 CatheterK251014 · DQY | 510(k) clearances |
| Apr 30, 2025 | APRO 45 Catheter and Alembic Aspiration TubingK251015 · NRY | 510(k) clearances |
| Apr 29, 2025 | APRO 55 Intermediate CatheterK250962 · DQY | 510(k) clearances |
| Apr 28, 2025 | APRO 55 Swift Catheter and Alembic Aspiration TubingK250958 · NRY | 510(k) clearances |
| Feb 24, 2025 | APRO 70 Swift Catheter and Alembic Aspiration TubingK243287 · NRY | 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
