Orange Book product · Generic (ANDA)
EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
At a glance
Dec 22, 2021
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 22, 2021
4 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Strength
600MG;200MG;300MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 213541
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
- 2006ATRIPLABrand (NDA)
NDA 021937 · GILEAD SCIENCES
- 2024EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATEGeneric (ANDA)
ANDA 209061 · MYLAN
- 2023EFAVIRENZ; EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEGeneric (ANDA)
ANDA 201802 · CHARTWELL RX
- 2022EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATEGeneric (ANDA)
ANDA 203053 · HETERO LABS LTD V
- 2021EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATEGeneric (ANDA)
ANDA 204287 · MACLEODS PHARMS LTD
- 2019EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATEGeneric (ANDA)
ANDA 206894 · CIPLA
- 2018EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATEGeneric (ANDA)
ANDA 091215 · TEVA PHARMS USA
- 2018EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATEGeneric (ANDA)
ANDA 203041 · 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.
