Orange Book product · Generic (ANDA)
ENTECAVIR
ENTECAVIR
At a glance
Oct 10, 2017
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 10, 2017
8 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
ENTECAVIR
Strength
0.5MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
ANDA 208782
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of ENTECAVIR
- 2005BARACLUDEBrand (NDA)
NDA 021798 · BRISTOL MYERS SQUIBB
- 2005BARACLUDEBrand (NDA)
NDA 021797 · BRISTOL MYERS SQUIBB
- 2024ENTECAVIRGeneric (ANDA)
ANDA 216857 · CONBA USA
- 2021ENTECAVIRGeneric (ANDA)
ANDA 208195 · YUNG SHIN PHARM
- 2020ENTECAVIRGeneric (ANDA)
ANDA 212106 · PHARMADAX
- 2020ENTECAVIRGeneric (ANDA)
ANDA 211978 · SUNSHINE
- 2019ENTECAVIRGeneric (ANDA)
ANDA 212201 · YAOPHARMA CO LTD
- 2019ENTECAVIRGeneric (ANDA)
ANDA 212126 · BRIGHTGENE
- 2019ENTECAVIRGeneric (ANDA)
ANDA 206226 · RISING
- 2018ENTECAVIRGeneric (ANDA)
ANDA 208721 · BRECKENRIDGE
- 2017ENTECAVIRGeneric (ANDA)
ANDA 205824 · ACCORD HLTHCARE
- 2017ENTECAVIRGeneric (ANDA)
ANDA 206745 · ZYDUS PHARMS
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.
