Orange Book product · Generic (ANDA)
DRONEDARONE HYDROCHLORIDE
DRONEDARONE HYDROCHLORIDE
Generic (ANDA)ANDA 205904DISCN LUPIN
At a glance
Jan 31, 2024
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 31, 2024
2 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
DRONEDARONE HYDROCHLORIDE
Strength
EQ 400MG BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
ANDA 205904
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of DRONEDARONE HYDROCHLORIDE
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.
