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EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE

NDA

EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE | N210649 | MACLEODS PHARMACEUTICALS 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
Mar 19, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 400MG;300MG;300MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Mar 15, 2019

No patent or exclusivity listings for this strength.