Assyro AI

FDA Orange Book · active-ingredient family

Granisetron hydrochloride

Granisetron hydrochloride is approved as 3 brand and 48 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:KYTRIL · NDA 020239

3

Brand (NDA)

48

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · injectable, solution, tablet

ProductApplicantApplicationTEApproved
KYTRILRLD×4ROCHENDA 020239—Sep 17, 2004
KYTRILRLDROCHENDA 021238—Jun 27, 2001
KYTRILRLD×2ROCHENDA 020305—Mar 16, 1995

Generic (ANDA) products (48)

ProductApplicantApplicationTEApproved
GRANISETRON HYDROCHLORIDEINTRA SANA LABSANDA 219282—Mar 17, 2025
GRANISETRON HYDROCHLORIDE×2YUNG SHIN PHARMANDA 202648—Jun 29, 2020
GRANISETRON HYDROCHLORIDEYUNG SHIN PHARMANDA 202647—Mar 06, 2020
GRANISETRON HYDROCHLORIDE×2PHARMOBEDIENTANDA 203454—Apr 04, 2017
GRANISETRON HYDROCHLORIDEPHARMOBEDIENTANDA 203453—Jan 31, 2017
GRANISETRON HYDROCHLORIDE×2EUGIA PHARMAANDA 204238—Jul 06, 2016
GRANISETRON HYDROCHLORIDEAM REGENTANDA 091274—Sep 22, 2010
GRANISETRON HYDROCHLORIDETAROANDA 090817—May 28, 2010
GRANISETRON HYDROCHLORIDE×2MYLAN ASIANDA 091136APApr 09, 2010
GRANISETRON HYDROCHLORIDEMYLAN ASIANDA 091137APApr 09, 2010
GRANISETRON HYDROCHLORIDE×2HIKMA FARMACEUTICAANDA 078629APDec 23, 2009
GRANISETRON HYDROCHLORIDE×2RISINGANDA 079078APSep 14, 2009
GRANISETRON HYDROCHLORIDEEPIC PHARMA LLCANDA 079119—Sep 10, 2009
GRANISETRON HYDROCHLORIDENATCO PHARMAANDA 078969ABJun 22, 2009
GRANISETRON HYDROCHLORIDESANDOZANDA 078534APApr 30, 2009
GRANISETRON HYDROCHLORIDE×2SANDOZANDA 078531APApr 30, 2009
GRANISETRON HYDROCHLORIDEDR REDDYS LABS LTDANDA 078846ABFeb 27, 2009
GRANISETRON HYDROCHLORIDE×2AMNEALANDA 078258APJun 30, 2008
GRANISETRON HYDROCHLORIDE×2BAXTER HLTHCARE CORPANDA 078198—Jun 30, 2008
GRANISETRON HYDROCHLORIDE×2BIONPHARMAANDA 078863APJun 30, 2008
GRANISETRON HYDROCHLORIDEBIONPHARMAANDA 078880APJun 30, 2008
GRANISETRON HYDROCHLORIDEDR REDDYSANDA 077297APJun 30, 2008
GRANISETRON HYDROCHLORIDEFRESENIUS KABI USAANDA 078090APJun 30, 2008
GRANISETRON HYDROCHLORIDEHIKMAANDA 077186APJun 30, 2008
GRANISETRON HYDROCHLORIDEHIKMAANDA 077187APJun 30, 2008
GRANISETRON HYDROCHLORIDE×2SANDOZ INCANDA 078835APJun 30, 2008
GRANISETRON HYDROCHLORIDEWOCKHARDT USAANDA 078564—Jun 30, 2008
GRANISETRON HYDROCHLORIDEWOCKHARDT USAANDA 078565—Jun 30, 2008
GRANISETRON HYDROCHLORIDE PRESERVATIVE FREEFRESENIUS KABI USAANDA 078096APJun 30, 2008
GRANISETRON HYDROCHLORIDEHIKMAANDA 077913APJun 26, 2008
GRANISETRON HYDROCHLORIDESANDOZANDA 078808—Apr 29, 2008
GRANISETRON HYDROCHLORIDEWOCKHARDT USAANDA 078566—Feb 29, 2008
GRANISOLINTRA SANA LABSANDA 078334—Feb 28, 2008
GRANISETRON HYDROCHLORIDEAPOTEX INCANDA 078843—Feb 27, 2008
GRANISETRON HYDROCHLORIDECHARTWELL MOLECULARANDA 078037ABFeb 27, 2008
GRANISETRON HYDROCHLORIDEORBION PHARMSANDA 078678ABFeb 13, 2008
GRANISETRON HYDROCHLORIDEAUROBINDO PHARMA USAANDA 078725—Jan 30, 2008
GRANISETRON HYDROCHLORIDETEVA PHARMS USAANDA 077963—Jan 03, 2008
GRANISETRON HYDROCHLORIDEAMNEALANDA 078262APDec 31, 2007
GRANISETRON HYDROCHLORIDEBAXTER HLTHCARE CORPANDA 078197—Dec 31, 2007
GRANISETRON HYDROCHLORIDEDR REDDYSANDA 078392APDec 31, 2007
GRANISETRON HYDROCHLORIDEFRESENIUS KABI USAANDA 078522APDec 31, 2007
GRANISETRON HYDROCHLORIDEHIKMAANDA 077177APDec 31, 2007
GRANISETRON HYDROCHLORIDE PRESERVATIVE FREEDR REDDYSANDA 077165—Dec 31, 2007
GRANISETRON HYDROCHLORIDEBARRANDA 078221—Dec 31, 2007
GRANISETRON HYDROCHLORIDEEPIC PHARMA LLCANDA 078260—Dec 31, 2007
GRANISETRON HYDROCHLORIDEHIKMAANDA 077842—Dec 31, 2007
GRANISETRON HYDROCHLORIDETEVA PHARMSANDA 078080—Dec 31, 2007

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.

Granisetron 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.

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