Orange Book product · Generic (ANDA)
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
At a glance
Aug 22, 2018
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 22, 2018
7 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Strength
100MG;150MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 209721
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
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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 206436 · PHARMOBEDIENT
- 2018EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEGeneric (ANDA)
ANDA 090513 · 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.
