Generic drug makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in IndiaLabelled 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 Biocon and its 3 subsidiaries with 44 drug applications, 3 510(k) clearances and 3 drug recalls. The most recent is a drug recall dated Mar 24, 2016: Simvastatin Tablets, USP 5 mg Rx only, a) 90 count (NDC 24658-0300-90) and b) 1000 count….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Biocon and its 3 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Mar 24, 2016 | Simvastatin Tablets, USP 5 mg Rx only, a) 90 count (NDC 24658-0300-90) and b) 1000 count (NDC 24658-0300-10 )bottles, Manufactured by: Blu CClass III · Subpotent Drug | Drug recalls |
| Nov 3, 1983 | HEP-2 CELLSK833360 · KIR | 510(k) clearances |
| Nov 3, 1983 | MRC-5 CELLSK833358 · KIR | 510(k) clearances |
| Nov 3, 1983 | WI-38 CELLSK833359 · KIR | 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
