Orange Book product · Brand (NDA)
EPZICOM
ABACAVIR SULFATE; LAMIVUDINE
At a glance
Aug 02, 2004
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 02, 2004
22 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
ABACAVIR SULFATE; LAMIVUDINE
Strength
EQ 600MG BASE;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 021652
Product number
001
Marketing status
DISCN
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.
- 2023ABACAVIR SULFATE AND LAMIVUDINEBrand (NDA)
NDA 204311 · PHARMOBEDIENT
- 2025ABACAVIR SULFATE AND LAMIVUDINEGeneric (ANDA)
ANDA 205412 · HETERO LABS LTD V
- 2024ABACAVIR SULFATE AND LAMIVUDINEGeneric (ANDA)
ANDA 212663 · MACLEODS PHARMS LTD
- 2022ABACAVIR SULFATE AND LAMIVUDINEGeneric (ANDA)
ANDA 216332 · LAURUS
- 2018ABACAVIR SULFATE AND LAMIVUDINEGeneric (ANDA)
ANDA 090159 · AUROBINDO PHARMA LTD
- 2018ABACAVIR SULFATE AND LAMIVUDINEGeneric (ANDA)
ANDA 208990 · ZYDUS PHARMS
- 2017ABACAVIR SULFATE AND LAMIVUDINEGeneric (ANDA)
ANDA 206151 · AUROBINDO PHARMA
- 2017ABACAVIR SULFATE AND LAMIVUDINEGeneric (ANDA)
ANDA 204990 · CHARTWELL RX
- 2017ABACAVIR SULFATE AND LAMIVUDINEGeneric (ANDA)
ANDA 091144 · CIPLA
- 2016ABACAVIR SULFATE AND LAMIVUDINEGeneric (ANDA)
ANDA 079246 · TEVA PHARMS USA
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.
