Is there a generic for Lamivudine; tenofovir disoproxil fumarate?

The FDA Orange Book does not currently list an approved generic (ANDA) for Lamivudine; tenofovir disoproxil fumarate. It is available as 3 brand (NDA) applications.

What is the reference-listed drug for Lamivudine; tenofovir disoproxil fumarate?

TEMIXYS (NDA 211284, CHARTWELL RX) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Lamivudine; tenofovir disoproxil fumarate are approved?

Lamivudine; tenofovir disoproxil fumarate is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Lamivudine; tenofovir disoproxil fumarate

Lamivudine; tenofovir disoproxil fumarate is approved in 3 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:TEMIXYS · NDA 211284

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · tablet

Product	Applicant	Application	TE	Approved
TEMIXYSRLD	CHARTWELL RX	NDA 211284	—	Nov 16, 2018
LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATERLD	AUROBINDO PHARMA LTD	NDA 022344	—	May 15, 2018
CIMDUORLD	MYLAN LABS LTD	NDA 022141	—	Feb 28, 2018

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.

Lamivudine; tenofovir disoproxil fumarate — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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