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 5 spellings of its name, each linked to the record. See the Viatris group view.
As of Nov 14, 2026, FDA's public records list Viatris and its 25 subsidiaries with 564 drug applications, 186 drug recalls, 12 510(k) clearances, 9 complete response letters, 4 warning letters and 1 OPDP letter. The most recent is an OPDP letter dated Jul 13, 2026: Untitled letter: TOBI PODHALER.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Viatris and its 25 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jul 13, 2026 | Untitled letter: TOBI PODHALEROffice of Prescription Drug Promotion | OPDP letters |
| Dec 19, 2024 | Warning letter: Data integrity, Stability, Out-of-specificationCDER | Warning letters |
| Jul 27, 2023 | Warning letter: DrugsCDER | Warning letters |
| Jan 13, 2023 | Complete response letter, NDA 204311Approved | Complete response letters |
| Aug 28, 2019 | Complete response letter, NDA 210605Approved | Complete response letters |
| Aug 6, 2019 | Complete response letter, NDA 204311Approved | Complete response letters |
| Jun 6, 2019 | Complete response letter, NDA 206610Approved | Complete response letters |
| Nov 9, 2018 | Warning letter: Cleaning validation, Process validation, StabilityCDER | Warning letters |
| May 17, 2018 | Complete response letter, NDA 210605Approved | 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 |
| Feb 14, 2014 | etomidate injection, USP, 2 mg/mL, packaged in a) 20 mg/10 mL (2 mg/mL), 10 mL Single Dose Vials (NDC 0069-0006-02), 10 x 10 mL vials per caClass II · Presence of Particulate Matter: Potential for small black particles to be present in individual vials, the potential for | Drug recalls |
| Oct 8, 1997 | DEY VIAL SODIUM CHLORIDE 3%K972778 · CAF | 510(k) clearances |
| May 22, 1991 | NEBU-SOL METERED DOSE DISPENSER (TM)K910239 · BSY | 510(k) clearances |
| May 15, 1990 | TROBICIN SUSCEPTIBILITY POWDERK902004 · LOP | 510(k) clearances |
| Feb 9, 1990 | ZEFAZONE SUSCEPTIBILITY POWDERK900455 · LOP | 510(k) clearances |
| Feb 29, 1988 | DEY-VIAL SODIUM CHLORIDE SOLUTION, USP, STERILEK880411 · CAF | 510(k) clearances |
| Jan 22, 1988 | DEY-PAK AND DEY-VIAL SODIUM CHLORIDE SOLUTION, USPK875024 · CCQ | 510(k) clearances |
| Jan 22, 1988 | DEY-PAK PURIFIED WATER, USP, STERILEK875011 · CCQ | 510(k) clearances |
| Jul 12, 1983 | OCULAR IRRIGATING CANNULAK831532 · HMX | 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
