Orange Book product · Generic (ANDA)
LAMIVUDINE
LAMIVUDINE
At a glance
Oct 31, 2014
Approved
Generic (ANDA)
Application
AA
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 31, 2014
11 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
LAMIVUDINE
Strength
10MG/ML
Dosage form
SOLUTION
Route
ORAL
TE code
AA
Application
ANDA 203564
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 077695 · AUROBINDO PHARMA
- 2016LAMIVUDINEGeneric (ANDA)
ANDA 077464 · AUROBINDO PHARMA
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.
