Orange Book product · Generic (ANDA)
VALPROATE SODIUM
VALPROATE SODIUM
Generic (ANDA)ANDA 078523TE APRX HIKMA FARMACEUTICA
At a glance
Feb 17, 2010
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 17, 2010
16 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
VALPROATE SODIUM
Strength
EQ 100MG BASE/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
ANDA 078523
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
Active-ingredient family
View full familyGeneric (ANDA) of VALPROATE SODIUM
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.
