Orange Book product · Brand (NDA)
EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE
EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
At a glance
Mar 15, 2019
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 15, 2019
7 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
Strength
400MG;300MG;300MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 210649
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a brand (NDA) product. Other products sharing this active ingredient are listed below.
- 2018EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATEBrand (NDA)
NDA 022343 · AUROBINDO PHARMA LTD
- 2018SYMFIBrand (NDA)
NDA 022142 · MYLAN LABS 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.
