Orange Book product · Generic (ANDA)
ENTACAPONE
ENTACAPONE
At a glance
Oct 03, 2018
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 03, 2018
7 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
ENTACAPONE
Strength
200MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 206669
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of ENTACAPONE
- 1999COMTANBrand (NDA)
NDA 020796 · ORION PHARMA
- 2022ENTACAPONEGeneric (ANDA)
ANDA 212601 · ALEMBIC
- 2017ENTACAPONEGeneric (ANDA)
ANDA 205792 · AJANTA PHARMA LTD
- 2017ENTACAPONEGeneric (ANDA)
ANDA 207210 · MACLEODS PHARMS LTD
- 2015ENTACAPONEGeneric (ANDA)
ANDA 203437 · AUROBINDO PHARMA LTD
- 2013ENTACAPONEGeneric (ANDA)
ANDA 202394 · PHARMOBEDIENT
- 2012ENTACAPONEGeneric (ANDA)
ANDA 078941 · WOCKHARDT BIO AG
- 2012ENTACAPONEGeneric (ANDA)
ANDA 090690 · SUN PHARM
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.
