Mylan
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 Viatris. FDA records under 4 spellings of its name, each linked to the record. See the Viatris group view.
- Drug applications: 237
- Drug recalls: 5
- Complete response letters: 2
Records by Year
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
Latest Records
Newest first across sources; each opens the record| Date | Record | Source |
|---|---|---|
| Aug 28, 2019 | Complete response letter, NDA 210605Approved | Complete response letters |
| May 17, 2018 | Complete response letter, NDA 210605Approved | Complete response letters |
| Dec 20, 2016 | Temozolomide Capsules, 100 mg, packaged in a) 5-count bottles (NDC 0378-5262-98), b) 14-count bottles (NDC 0378-5262-14), Rx only, Mylan PhaClass II · Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in th | Drug recalls |
| Dec 20, 2016 | Temozolomide Capsules, 250 mg, 5-count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA, NDC 0378-5265-98.Class II · Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in th | Drug recalls |
| Dec 20, 2016 | Temozolomide Capsules, 180 mg, packaged in a) 5-count bottles (NDC 0378-5264-98), b) 14-count bottles (NDC 0378-5264-14), Rx only, Mylan PhaClass II · Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in th | Drug recalls |
| Dec 20, 2016 | Temozolomide Capsules, 140 mg, packaged in a) 5-count bottles (NDC 0378-5263-98), b) 14-count bottles (NDC 0378-5263-14), Rx only, Mylan PhaClass II · Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in th | Drug recalls |
| Jun 29, 2012 | Mylan, Tacrolimus Capsules 0.5 mg, 100 count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-2045-01Class II · Failed USP Content Uniformity Requirements: OOS result reported on retained samples. | Drug recalls |
Canada and Imports
Matched by company name- FDA import refusals since 2024
- 6 shipment lines, through Oct 23, 2026
Names and Identifiers
- Appears as
- Website
- viatris.com
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