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 Boehringer IngelheimLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record. See the Boehringer Ingelheim group view.
As of Nov 14, 2026, FDA's public records list Roxane Laboratories with 128 drug applications, 2 drug recalls, 1 complete response letter and 1 510(k) clearance. The most recent is a drug recall dated Dec 22, 2016: Furosemide Tablets USP, 20 mg, 1000 count bottles, Rx only, Roxane Laboratories, Inc., C….
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.
| Dec 22, 2016 | Furosemide Tablets USP, 20 mg, 1000 count bottles, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-4297-31.Class II · Failed Tablet/Capsule Specifications: An unusually thick tablet was reported through a complaint. | Drug recalls |
| Dec 14, 2016 | Azelastine Hydrochloride Nasal Solution (Nasal Spray), 0.1% (137 mcg per spray), packaged in 30 mL bottles, Rx only, Distributed by: West-WaClass III · Defective Delivery System: out of specification result for droplet size distribution at the d90 measurement testing duri | Drug recalls |
| May 3, 2013 | Complete response letter, NDA 203856Approved | Complete response letters |
| Nov 16, 1982 | SALIVA SUBSTITUTEK822971 · LFD | 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
