Golimumab
Sold as Simponi, Simponi Aria. Every FDA application for this active ingredient.
- First approved: Apr 24, 2009
- Applications: 2
- New uses approved: 12
- Complete response letters: 0
Applications
NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Apr 24, 2009 | SimponiBLA 125289 · New molecular entity | Centocor Ortho Biotech Inc | 32 | Marketed |
| Jul 18, 2013 | Simponi AriaBLA 125433 | Janssen Biotech | 17 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Drugs@FDA