Orange Book product · Generic (ANDA)
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
At a glance
Jan 26, 2018
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 26, 2018
8 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Strength
200MG;300MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 090513
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
- 2016TRUVADABrand (NDA)
NDA 021752 · GILEAD
- 2023EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEGeneric (ANDA)
ANDA 211640 · AUROBINDO PHARMA LTD
- 2021EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEGeneric (ANDA)
ANDA 201806 · HETERO LABS LTD III
- 2021EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEGeneric (ANDA)
ANDA 212689 · ZYDUS PHARMS
- 2021EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEGeneric (ANDA)
ANDA 208740 · APOTEX
- 2021EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEGeneric (ANDA)
ANDA 204131 · CHARTWELL RX
- 2021EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEGeneric (ANDA)
ANDA 090958 · CIPLA
- 2021EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEGeneric (ANDA)
ANDA 091055 · STRIDES PHARMA
- 2020EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEGeneric (ANDA)
ANDA 203442 · MACLEODS PHARMS LTD
- 2019EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEGeneric (ANDA)
ANDA 212114 · LAURUS
- 2018EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEGeneric (ANDA)
ANDA 209721 · AMNEAL PHARMS CO
- 2018EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEGeneric (ANDA)
ANDA 206436 · PHARMOBEDIENT
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.
