Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DIVALPROEX, USP · 2 trials · 1 indication
Maximum plasma concentration (micrograms/mL)
Area under the concentration time curve from time zero to the last measurable time point. (micrograms x mL/hour)
Area under the concentration time curve from time zero to infinity (micrograms x mL/hour)
| Arm | Type | Description |
|---|---|---|
| Divalproex Sodium | EXPERIMENTAL | DIVALPROEX SODIUM DELAYED-RELEASE TABLETS, USP, 500 MG - Mylan Pharmaceuticals Inc |
| Depakote Tablets | ACTIVE_COMPARATOR | DEPAKOTE® Tablets, 500 MG Abbott Laboratories |
| Test: Divalproex Sodium | EXPERIMENTAL | DIVALPROEX SODIUM DELAYED-RELEASE TABLETS, USP, 500 MG |
| Reference: Depakote Tablets | ACTIVE_COMPARATOR | DEPAKOTE® Tablets, 500 MG Abbott Laboratories |
| Name | Type | Description |
|---|---|---|
| DEPAKOTE® Tablets, 500 MG | DRUG | 1 x 500 mg Tablet, under fed conditions |
| DIVALPROEX SODIUM DELAYED-RELEASE TABLETS, USP, 500 MG | DRUG | 1 x 500 mg Tablet, under fed conditions |
Inclusion Criteria: 1. Age: 18 years and older. 2. Sex: Females not of child bearing potential and males. * No hormonal contraceptives or hormonal replacement therapies are permitted in this study. * Women will not be considered of childbearing potential if one of the following is reported a...