Orange Book product · Brand (NDA)
TIKOSYN
DOFETILIDE
At a glance
Oct 01, 1999
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 01, 1999
27 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
DOFETILIDE
Strength
0.25MG
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
NDA 020931
Product number
002
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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.
- 2022DOFETILIDEGeneric (ANDA)
ANDA 210018 · TEVA PHARMS USA
- 2022DOFETILIDEGeneric (ANDA)
ANDA 215323 · RK PHARMA
- 2021DOFETILIDEGeneric (ANDA)
ANDA 212750 · GRANULES
- 2020DOFETILIDEGeneric (ANDA)
ANDA 213338 · ACCORD HLTHCARE
- 2020DOFETILIDEGeneric (ANDA)
ANDA 213220 · MSN
- 2019DOFETILIDEGeneric (ANDA)
ANDA 212410 · INGENUS PHARMS LLC
- 2019DOFETILIDEGeneric (ANDA)
ANDA 211223 · PRINSTON INC
- 2019DOFETILDEGeneric (ANDA)
ANDA 210740 · AUROBINDO PHARMA LTD
- 2018DOFETILIDEGeneric (ANDA)
ANDA 208519 · STRIDES PHARMA INTL
- 2018DOFETILIDEGeneric (ANDA)
ANDA 210466 · SUN PHARM
- 2018DOFETILIDEGeneric (ANDA)
ANDA 208625 · BIONPHARMA
- 2018DOFETILIDEGeneric (ANDA)
ANDA 207746 · SIGMAPHARM LABS LLC
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.
