Orange Book product · Generic (ANDA)
LAMIVUDINE
LAMIVUDINE
At a glance
Nov 21, 2016
Approved
Generic (ANDA)
Application
AA
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 21, 2016
9 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
LAMIVUDINE
Strength
10MG/ML
Dosage form
SOLUTION
Route
ORAL
TE code
AA
Application
ANDA 077695
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of LAMIVUDINE
- 1998EPIVIR-HBVBrand (NDA)
NDA 021004 · GLAXOSMITHKLINE
- 1998EPIVIR-HBVBrand (NDA)
NDA 021003 · GLAXOSMITHKLINE
- 1995EPIVIRBrand (NDA)
NDA 020596 · VIIV HLTHCARE
- 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 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.

