Orange Book product · Brand (NDA)
DEPAKOTE ER
DIVALPROEX SODIUM
At a glance
May 31, 2002
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 31, 2002
24 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
DIVALPROEX SODIUM
Strength
EQ 250MG VALPROIC ACID
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
AB
Application
NDA 021168
Product number
002
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 1990DEPAKOTE CPBrand (NDA)
NDA 019794 · ABBOTT
- 1989DEPAKOTEBrand (NDA)
NDA 019680 · ABBVIE
- 1984DEPAKOTEBrand (NDA)
NDA 018723 · ABBVIE
- 2025DIVALPROEX SODIUMGeneric (ANDA)
ANDA 217358 · MANKIND PHARMA
- 2024DIVALPROEX SODIUMGeneric (ANDA)
ANDA 218793 · ALEMBIC
- 2023DIVALPROEX SODIUMGeneric (ANDA)
ANDA 215527 · ANNORA PHARMA
- 2022DIVALPROEX SODIUMGeneric (ANDA)
ANDA 214643 · UNICHEM
- 2021DIVALPROEX SODIUMGeneric (ANDA)
ANDA 214462 · YICHANG HUMANWELL
- 2020DIVALPROEX SODIUMGeneric (ANDA)
ANDA 211505 · TEVA PHARMS USA
- 2020DIVALPROEX SODIUMGeneric (ANDA)
ANDA 213181 · AJANTA PHARMA LTD
- 2019DIVALPROEX SODIUMGeneric (ANDA)
ANDA 209286 · LUPIN
- 2015DIVALPROEX SODIUMGeneric (ANDA)
ANDA 203730 · AMNEAL PHARMS
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
