Drugs / Depakote ER
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (4) | US (FDA) | DEPAKOTE ER | — | 2003-08-14 – 2009-10-15 | fda.gov ↗ |
| Approved | US (FDA) | DEPAKOTE ER | — | 2000-08-04 | fda.gov ↗ |
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 31 trial | ||||||
| Phase 3 | NCT00315900 | May 2006 → Dec 2007 | dementia | Tuscaloosa Research & Education Advancement Corporation | Terminated | No outcome recorded |
| Phase 43 trials · 1 met primary | ||||||
| Phase 4 | NCT00211250 | Jul 2005 → Jul 2006 | mood disorder | Joliet Center for Clinical Research | Completed | No outcome recorded |
| Phase 4 | NCT00226343 | Aug 2003 → Jan 2006 | bipolar disorder | Cambridge Health Alliance | Completed | Met primary |
| Phase 4 | NCT00177567 | Jul 2001 → Jan 2004 | bipolar disorder | University of Pittsburgh | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT00203242 | Jul 2003 → Sep 2006 | cluster headache syndrome | Thomas Jefferson University | Completed | No outcome recorded |
| — | NCT00222482 | Mar 2003 → Sep 2005 | borderline personality disorder | University of Minnesota | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 1 | NCT00648076 Comparator | Dec 2004 | — | Mylan Pharmaceuticals Inc | Completed | No outcome recorded |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Depakote-ER | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00177567 ↗ |
| Known as | Divalproex Sodium | “Mylan's divalproex sodium 500 mg extended-release tablets to Abbott's Depakote ER® 500 mg tablets” NCT00648076 ↗ |
| Route | Oral | “Prior to leaving the office, the research nurse or study physician will give the subject an oral dose of the second study medication, 1000mg of Depakote ER.” NCT00203242 ↗ |