Viewing data from:

EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE

NDA

EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE | N022343 | AUROBINDO PHARMA LTD

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Aug 21, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 600MG;300MG;300MG

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Aug 15, 2018

No patent or exclusivity listings for this strength.