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FDA Orange Book · active-ingredient family

Lamivudine; zidovudine

Lamivudine; zidovudine is approved as 2 brand and 12 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:COMBIVIR · NDA 020857

2

Brand (NDA)

12

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
COMBIVIRRLDVIIV HLTHCARENDA 020857—Sep 26, 1997
LAMIVUDINE AND ZIDOVUDINEPHARMACARENDA 022018—Mar 17, 2017

Generic (ANDA) products (12)

ProductApplicantApplicationTEApproved
LAMIVUDINE AND ZIDOVUDINEPHARMOBEDIENTANDA 079079—Aug 12, 2019
LAMIVUDINE AND ZIDOVUDINECIPLAANDA 077411ABSep 07, 2018
LAMIVUDINE AND ZIDOVUDINEMACLEODS PHARMS LTDANDA 090679ABAug 29, 2018
LAMIVUDINE AND ZIDOVUDINEEPIC PHARMA LLCANDA 206375ABApr 10, 2018
LAMIVUDINE AND ZIDOVUDINEAUROBINDO PHARMAANDA 077558ABMay 05, 2017
LAMIVUDINE AND ZIDOVUDINEHETERO LABS LTD IIIANDA 079124ABSep 17, 2015
LAMIVUDINE AND ZIDOVUDINEPHARMOBEDIENTANDA 079128ABMay 13, 2015
LAMIVUDINE AND ZIDOVUDINENATCOANDA 204005—Aug 28, 2014
LAMIVUDINE AND ZIDOVUDINEHETERO LABS LTD VANDA 203259ABFeb 03, 2014
LAMIVUDINE AND ZIDOVUDINEAUROBINDO PHARMA LTDANDA 202418—May 15, 2012
LAMIVUDINE AND ZIDOVUDINELUPIN LTDANDA 090246—May 15, 2012
LAMIVUDINE AND ZIDOVUDINECHARTWELL RXANDA 079081—May 25, 2011

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; zidovudine — frequently asked questions

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

Agent CTA Background

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