Genentech
Biotech companyAI in United StatesAI, part of Roche. FDA records under 6 spellings of its name, each linked to the record. See the Roche group view.
- Drug applications: 42
- Drug recalls: 11
- Complete response letters: 1
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 |
|---|---|---|
| Nov 23, 2020 | Complete response letter, NDA 214410/Original 2, NDA 210854/S-05, NDA 210854/S-09Approved | Complete response letters |
| Mar 13, 2017 | Cotellic (cobimetinib) Tablets, 20 mg, 63 count bottle, Rx Only, Made in Switzerland. Distributed by Genentech USA, Inc., South Francisco, CClass II · Superpotent Drug: An oversized tablet was found in a bottle. | Drug recalls |
Canada and Imports
Matched by company name- FDA import refusals since 2024
- 1 shipment lines, through Oct 23, 2026
Names and Identifiers
- Appears as
- Website
- gene.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