Orange Book product · Brand (NDA)
EPIVIR
LAMIVUDINE
At a glance
Nov 17, 1995
Approved
Brand (NDA)
Application
AA
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 17, 1995
31 yr ago
Today
Pharmaceutical detail
Active ingredient
LAMIVUDINE
Strength
10MG/ML
Dosage form
SOLUTION
Route
ORAL
TE code
AA
Application
NDA 020596
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.
- 1998EPIVIR-HBVBrand (NDA)
NDA 021004 · GLAXOSMITHKLINE
- 1998EPIVIR-HBVBrand (NDA)
NDA 021003 · GLAXOSMITHKLINE
- 1995EPIVIRBrand (NDA)
NDA 020564 · VIIV HLTHCARE
- 2023LAMIVUDINEGeneric (ANDA)
ANDA 091475 · HETERO LABS LTD III
- 2019LAMIVUDINEGeneric (ANDA)
ANDA 090198 · MACLEODS PHARMS LTD
- 2019LAMIVUDINEGeneric (ANDA)
ANDA 211306 · ANNORA
- 2019LAMIVUDINEGeneric (ANDA)
ANDA 078545 · PHARMOBEDIENT
- 2018LAMIVUDINEGeneric (ANDA)
ANDA 090457 · STRIDES PHARMA
- 2017LAMIVUDINEGeneric (ANDA)
ANDA 077221 · CIPLA
- 2016LAMIVUDINEGeneric (ANDA)
ANDA 077695 · AUROBINDO PHARMA
- 2016LAMIVUDINEGeneric (ANDA)
ANDA 077464 · AUROBINDO PHARMA
- 2016LAMIVUDINEGeneric (ANDA)
ANDA 203586 · BRECKENRIDGE
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.
