Assyro AI

FDA Orange Book · active-ingredient family

Ondansetron hydrochloride

Ondansetron hydrochloride is approved as 4 brand and 68 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ZOFRAN · NDA 020605

4

Brand (NDA)

68

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · injectable, solution, tablet

ProductApplicantApplicationTEApproved
ZOFRANRLDSANDOZNDA 020605—Jan 24, 1997
ZOFRAN AND DEXTROSE IN PLASTIC CONTAINERRLDGLAXOSMITHKLINENDA 020403—Jan 31, 1995
ZOFRANRLD×3SANDOZNDA 020103—Dec 31, 1992
ZOFRANRLD×2SANDOZNDA 020007—Jan 04, 1991

Generic (ANDA) products (68)

ProductApplicantApplicationTEApproved
ONDANSETRON HYDROCHLORIDERISINGANDA 204906—Jul 31, 2017
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEACCORD HLTHCAREANDA 206845—Mar 10, 2016
ONDANSETRON HYDROCHLORIDEACCORD HLTHCAREANDA 206846APJul 13, 2015
ONDANSETRON HYDROCHLORIDEQILU PHARM HAINANANDA 203711APSep 08, 2014
ONDANSETRON HYDROCHLORIDE×2IPCA LABS LTDANDA 203761ABJan 23, 2014
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEFRESENIUS KABI USAANDA 202253APJul 19, 2013
ONDANSETRON HYDROCHLORIDEBAXTER HLTHCARE CORPANDA 078288—Feb 22, 2013
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEBAXTER HLTHCARE CORPANDA 078287APFeb 22, 2013
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEAVET LIFESCIENCESANDA 078945—Jan 03, 2013
ONDANSETRON HYDROCHLORIDEEUGIA PHARMAANDA 202599—Dec 21, 2012
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEUGIA PHARMAANDA 202600—Dec 21, 2012
ONDANSETRON HYDROCHLORIDEGLAND PHARMA LTDANDA 090648APJun 15, 2012
ONDANSETRON HYDROCHLORIDE×3TAROANDA 077729—Mar 28, 2011
ONDANSETRON HYDROCHLORIDEAMNEAL PHARMSANDA 091483AAJan 31, 2011
ONDANSETRON HYDROCHLORIDECHARTWELL MOLECULARANDA 091342AAJan 27, 2011
ONDANSETRON HYDROCHLORIDELANNETT CO INCANDA 090883—Aug 05, 2010
ONDANSETRON HYDROCHLORIDEAVET LIFESCIENCESANDA 090424—Apr 16, 2010
ONDANSETRON HYDROCHLORIDECHARTWELL MOLECULARANDA 090116—Apr 14, 2010
ONDANSETRON HYDROCHLORIDEGLAND PHARMA LTDANDA 079224APSep 25, 2009
ONDANSETRON HYDROCHLORIDELUITPOLDANDA 079039—Nov 18, 2008
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEAM REGENTANDA 079032—Nov 18, 2008
ONDANSETRON HYDROCHLORIDEONESOURCE SPECIALTYANDA 078257—Apr 23, 2008
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEONESOURCE SPECIALTYANDA 078244—Apr 23, 2008
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREETARO PHARMS IRELANDANDA 078014—Mar 21, 2008
ONDANSETRON HYDROCHLORIDETAROANDA 077009—Nov 30, 2007
ONDANSETRON HYDROCHLORIDEAUROBINDO PHARMAANDA 078776AANov 28, 2007
ONDANSETRON HYDROCHLORIDE×3HIKMA INTL PHARMSANDA 077545—Sep 06, 2007
ONDANSETRON HYDROCHLORIDE×3AUROBINDO PHARMAANDA 078539ABJul 31, 2007
ONDANSETRON HYDROCHLORIDESANDOZANDA 077430APJun 27, 2007
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREESANDOZANDA 077551APJun 27, 2007
ONDANSETRON HYDROCHLORIDEPHARM ASSOCANDA 078127AAJun 25, 2007
ONDANSETRON HYDROCHLORIDE×2APOTEXANDA 077306—Jun 25, 2007
ONDANSETRON HYDROCHLORIDE×3CHARTWELL MOLECULESANDA 077303ABJun 25, 2007
ONDANSETRON HYDROCHLORIDE×3CHARTWELL RXANDA 077517—Jun 25, 2007
ONDANSETRON HYDROCHLORIDE×3GLENMARK PHARMS LTDANDA 077535ABJun 25, 2007
ONDANSETRON HYDROCHLORIDE×2NATCO PHARMA LTDANDA 077851ABJun 25, 2007
ONDANSETRON HYDROCHLORIDE×3PLIVA HRVATSKA DOOANDA 077112—Jun 25, 2007
ONDANSETRON HYDROCHLORIDE×3RISINGANDA 076930—Jun 25, 2007
ONDANSETRON HYDROCHLORIDE×2SUN PHARM INDS (IN)ANDA 077050—Jun 25, 2007
ONDANSETRON HYDROCHLORIDE×3TEVAANDA 076252—Jun 25, 2007
ONDANSETRON HYDROCHLORIDESAGENT PHARMSANDA 078180—Mar 26, 2007
ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINERHOSPIRAANDA 076978—Feb 26, 2007
ONDANSETRON HYDROCHLORIDEHOSPIRAANDA 077840—Jan 19, 2007
ONDANSETRON HYDROCHLORIDEAM REGENTANDA 077582—Dec 26, 2006
ONDANSETRON HYDROCHLORIDEAPOTEX INCANDA 077368—Dec 26, 2006
ONDANSETRON HYDROCHLORIDEFRESENIUS KABI USAANDA 076974APDec 26, 2006
ONDANSETRON HYDROCHLORIDEHIKMAANDA 076967APDec 26, 2006
ONDANSETRON HYDROCHLORIDEHIKMAANDA 077365APDec 26, 2006
ONDANSETRON HYDROCHLORIDEHIKMA FARMACEUTICAANDA 076781—Dec 26, 2006
ONDANSETRON HYDROCHLORIDEHOSPIRAANDA 076695—Dec 26, 2006
ONDANSETRON HYDROCHLORIDEHOSPIRAANDA 077473APDec 26, 2006
ONDANSETRON HYDROCHLORIDEPLIVA HRVATSKA DOOANDA 077544—Dec 26, 2006
ONDANSETRON HYDROCHLORIDESUN PHARM INDS (IN)ANDA 077172—Dec 26, 2006
ONDANSETRON HYDROCHLORIDEWOCKHARDT BIO AGANDA 077577APDec 26, 2006
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEAM REGENTANDA 077387—Dec 26, 2006
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEAPOTEX INCANDA 077343—Dec 26, 2006
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEFRESENIUS KABI USAANDA 076972APDec 26, 2006
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEHIKMAANDA 077011APDec 26, 2006
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEHIKMAANDA 077541APDec 26, 2006
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEHIKMA FARMACEUTICAANDA 076780—Dec 26, 2006
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEHOSPIRAANDA 076696—Dec 26, 2006
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEHOSPIRAANDA 077548APDec 26, 2006
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREESUN PHARM INDS LTDANDA 077173—Dec 26, 2006
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEWOCKHARDT BIO AGANDA 077716APDec 26, 2006
ONDANSETRON HYDROCHLORIDEHIKMAANDA 076960AADec 26, 2006
ONDANSETRON HYDROCHLORIDE×4DR REDDYS LABS LTDANDA 076183ABDec 26, 2006
ONDANSETRON HYDROCHLORIDETEVAANDA 076876—Nov 22, 2006
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREETEVAANDA 076759—Nov 22, 2006

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.

Ondansetron hydrochloride — 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