Orange Book product · Generic (ANDA)
ENTECAVIR
ENTECAVIR
At a glance
Sep 25, 2019
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 25, 2019
6 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
ENTECAVIR
Strength
0.5MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 212126
Product number
001
Marketing status
RX
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 206226 · RISING
- 2018ENTECAVIRGeneric (ANDA)
ANDA 208721 · BRECKENRIDGE
- 2017ENTECAVIRGeneric (ANDA)
ANDA 208782 · PRINSTON INC
- 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.
