Orange Book product · Brand (NDA)
BARACLUDE
ENTECAVIR
At a glance
Mar 29, 2005
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 29, 2005
21 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
ENTECAVIR
Strength
0.5MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 021797
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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.
- 2005BARACLUDEBrand (NDA)
NDA 021798 · 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 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.
