Orange Book product · Brand (NDA)
DEPAKENE
VALPROIC ACID
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
VALPROIC ACID
Strength
250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
SYRUP
Route
ORAL
TE code
Not listed
Application
NDA 018082
Product number
001
Marketing status
DISCN
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.
- 2008STAVZORBrand (NDA)
NDA 022152 · BIONPHARMA
- —DEPAKENEBrand (NDA)
NDA 018081 · ABBVIE
- 2019VALPROIC ACIDGeneric (ANDA)
ANDA 207611 · HIBROW HLTHCARE
- 2013VALPROIC ACIDGeneric (ANDA)
ANDA 091037 · SUN PHARM INDS LTD
- 2010VALPROIC ACIDGeneric (ANDA)
ANDA 090517 · QUAGEN
- 2006VALPROIC ACIDGeneric (ANDA)
ANDA 077960 · LANNETT CO INC
- 2005VALPROIC ACIDGeneric (ANDA)
ANDA 077105 · PAI HOLDINGS
- 2000VALPROIC ACIDGeneric (ANDA)
ANDA 075782 · CHARTWELL RX
- 2000VALPROIC ACIDGeneric (ANDA)
ANDA 075379 · PHARM ASSOC
- 1995VALPROIC ACIDGeneric (ANDA)
ANDA 074060 · HIKMA
- 1993VALPROIC ACIDGeneric (ANDA)
ANDA 073484 · BIONPHARMA
- 1992VALPROIC ACIDGeneric (ANDA)
ANDA 073178 · ANI 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.
