Orange Book product · Brand (NDA)
COMTAN
ENTACAPONE
At a glance
Oct 19, 1999
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 19, 1999
27 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
ENTACAPONE
Strength
200MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 020796
Product number
001
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.
- 2022ENTACAPONEGeneric (ANDA)
ANDA 212601 · ALEMBIC
- 2018ENTACAPONEGeneric (ANDA)
ANDA 206669 · SUNSHINE
- 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.
