Valproate Sodium
Sold as Depacon. Every FDA application for this active ingredient: 1 branded and 4 generic.
- First approved: Dec 30, 1996
- Applications: 5
- New uses approved: 1
- 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 |
|---|---|---|---|---|
| Dec 30, 1996 | DepaconNDA 20593 · New dosage form | Abbvie | 32 | Discontinued |
| Nov 14, 2002 | Valproate SodiumANDA 76295 | Sagent | 2 | Marketed |
| Jun 26, 2003 | Valproate SodiumANDA 76539 | Fresenius Kabi USA | 9 | Marketed |
| Feb 17, 2010 | Valproate SodiumANDA 78523 | Hikma Farmaceutica | 12 | Marketed |
| Dec 22, 2021 | Valproate SodiumANDA 208120 | Pharmobedient | 1 | Discontinued |
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