Orange Book product · Brand (NDA)
SYMFI
EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
At a glance
Mar 22, 2018
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 22, 2018
8 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
Strength
600MG;300MG;300MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 022142
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.
- 2019EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATEBrand (NDA)
NDA 210649 · MACLEODS PHARMS LTD
- 2018EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATEBrand (NDA)
NDA 022343 · AUROBINDO PHARMA LTD
- 2018SYMFI LOBrand (NDA)
NDA 208255 · MYLAN
- 2020EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATEGeneric (ANDA)
ANDA 213038 · LAURUS
- 2020EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATEGeneric (ANDA)
ANDA 212786 · LAURUS
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.
