Orange Book product · Generic (ANDA)
PRIMIDONE
PRIMIDONE
At a glance
Jan 23, 2024
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 23, 2024
2 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
PRIMIDONE
Strength
50MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 218366
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of PRIMIDONE
- —MYSOLINEBrand (NDA)
NDA 009170 · VALEANT
- 2022PRIMIDONEGeneric (ANDA)
ANDA 214896 · RUBICON RESEARCH
- 2008PRIMIDONEGeneric (ANDA)
ANDA 040862 · CHARTWELL RX
- 2008PRIMIDONEGeneric (ANDA)
ANDA 040866 · AMNEAL PHARM
- 2008PRIMIDONEGeneric (ANDA)
ANDA 040717 · IMPAX LABS
- 2006PRIMIDONEGeneric (ANDA)
ANDA 040667 · HIKMA INTL PHARMS
- 2005PRIMIDONEGeneric (ANDA)
ANDA 040626 · TP ANDA HOLDINGS
- 2005PRIMIDONEGeneric (ANDA)
ANDA 040586 · OXFORD PHARMS
- 2001PRIMIDONEGeneric (ANDA)
ANDA 084903 · LANNETT
- —PRIMIDONEGeneric (ANDA)
ANDA 083551 · WATSON LABS
- —PRIMIDONEGeneric (ANDA)
ANDA 085052 · WATSON LABS
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.
