Orange Book product · Brand (NDA)
MYSOLINE
PRIMIDONE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
PRIMIDONE
Strength
50MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 009170
Product number
003
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
- 2024PRIMIDONEGeneric (ANDA)
ANDA 218366 · CARNEGIE
- 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.
