Orange Book product · Generic (ANDA)
DOFETILIDE
DOFETILIDE
At a glance
Dec 17, 2019
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 17, 2019
6 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
DOFETILIDE
Strength
0.125MG
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
ANDA 211223
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of DOFETILIDE
- 1999TIKOSYNBrand (NDA)
NDA 020931 · PFIZER
- 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
- 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.
