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., part of Viatris. FDA records under 7 spellings of its name, each linked to the record. See the Viatris group view.
As of Nov 14, 2026, FDA's public records list Mylan Laboratories with 80 drug applications, 15 drug recalls, 4 complete response letters and 1 warning letter. The most recent is a drug recall dated Oct 7, 2019: Rifampin for Injection, USP, 600 mg/vial, Rx only, Manufactured for: Mylan Institutiona….
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.
| Oct 7, 2019 | Rifampin for Injection, USP, 600 mg/vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103; NDC 67457-445-60.Class II · Failed Impurities/Degradation Specifications: discoloration due to elevated unknown impurity results which could decreas | Drug recalls |
| Jun 6, 2019 | Complete response letter, NDA 206610Approved | Complete response letters |
| Dec 6, 2017 | Complete response letter, NDA 206610Approved | Complete response letters |
| Apr 3, 2017 | Warning letter: Data integrity, Out-of-specification, Quality unitCDER | Warning letters |
| Feb 1, 2017 | Complete response letter, NDA 206610Approved | Complete response letters |
| Mar 10, 2016 | Complete response letter, NDA 206610Approved | Complete response letters |
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
