Orange Book product
DIVALPROEX SODIUM EQ 500MG VALPROIC ACID
Orange Book ANDA 203730 · AMNEAL PHARMACEUTICALS · Prescription
Key facts
| Proprietary name | DIVALPROEX SODIUM |
|---|---|
| Active ingredients | DIVALPROEX SODIUM |
| Strength | EQ 500MG VALPROIC ACID |
| Dosage form | TABLET, EXTENDED RELEASE |
| Route | ORAL |
| Application | ANDA203730 |
| Applicant holder | AMNEAL PHARMACEUTICALS |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AB |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | Yes |
| Approval date | May 29, 2015 |
At a glance
- 10–99 Marketed products with the same ingredient, strength and form
- 1–9 Products in this application
- No Reference listed drug
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Orange Book products
The FDA Orange Book lists approved drug products with their therapeutic equivalence (TE) codes, reference listed drugs and marketing status. Products approved before 1982 show an approval date of Jan 1, 1982.