Orange Book product · Brand (NDA)
STAVZOR
VALPROIC ACID
At a glance
Jul 29, 2008
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 29, 2008
18 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
VALPROIC ACID
Strength
500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 022152
Product number
003
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.
- —DEPAKENEBrand (NDA)
NDA 018081 · ABBVIE
- —DEPAKENEBrand (NDA)
NDA 018082 · 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.
