Assyro AI

FDA Orange Book · active-ingredient family

Zidovudine

Zidovudine is approved as 6 brand and 13 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:RETROVIR · NDA 020518

6

Brand (NDA)

13

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule, injectable, solution, tablet

ProductApplicantApplicationTEApproved
RETROVIRRLD×2VIIV HLTHCARENDA 020518—Oct 04, 1996
RETROVIRRLDVIIV HLTHCARENDA 019951—Feb 02, 1990
RETROVIRRLDVIIV HLTHCARENDA 019910AASep 28, 1989
RETROVIRRLDVIIV HLTHCARENDA 019655ABMar 19, 1987
ZIDOVUDINEPHARMOBEDIENTNDA 200732—Feb 23, 2011
ZIDOVUDINEAUROBINDO PHARMANDA 022294—Jul 23, 2009

Generic (ANDA) products (13)

ProductApplicantApplicationTEApproved
ZIDOVUDINELIAONING CHENGDAANDA 204538—Nov 26, 2013
ZIDOVUDINEHEC PHARMANDA 202058—Oct 07, 2011
ZIDOVUDINECIPLAANDA 090561ABOct 27, 2010
ZIDOVUDINEAM REGENTANDA 091457—May 06, 2010
ZIDOVUDINECIPLA LTDANDA 077981AAJun 26, 2008
ZIDOVUDINEHETERO LABS LTD IIIANDA 090092ABApr 25, 2008
ZIDOVUDINEPHARMOBEDIENTANDA 078922—Feb 14, 2008
ZIDOVUDINECIPLA LTDANDA 078349ABMay 23, 2007
ZIDOVUDINEAUROBINDO PHARMA LTDANDA 078128ABMar 27, 2006
ZIDOVUDINEAUROBINDOANDA 077268AASep 19, 2005
ZIDOVUDINEAUROBINDOANDA 077267ABSep 19, 2005
ZIDOVUDINEHIKMAANDA 076844—Sep 19, 2005
ZIDOVUDINERANBAXY LABS LTDANDA 077327—Sep 19, 2005

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.

Zidovudine — frequently asked questions

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

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo