Orange Book product · Generic (ANDA)
VALPROIC ACID
VALPROIC ACID
At a glance
Dec 15, 2000
Approved
Generic (ANDA)
Application
AA
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 15, 2000
25 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
VALPROIC ACID
Strength
250MG/5ML
Dosage form
SYRUP
Route
ORAL
TE code
AA
Application
ANDA 075379
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
Active-ingredient family
View full familyGeneric (ANDA) of VALPROIC ACID
- 2008STAVZORBrand (NDA)
NDA 022152 · BIONPHARMA
- —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
- 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.
