FDA Orange Book · active-ingredient family
Granisetron hydrochloride
Granisetron hydrochloride: 3 brands, 48 generics; first approved Dec 29, 1993; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 48 ANDA applications approved.
Brands (NDA)
3
Generics (ANDA)
48
Listed patents
0
Presentations
66
Brand (NDA) products
Originator applications
- KYTRILRLDROCHENDA 02023920044 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 3MG BASE/ML INJECTABLE INJECTION Discontinued - EQ 4MG BASE/4ML (EQ 1MG BASE/ML) INJECTABLE INJECTION Discontinued - EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) INJECTABLE INJECTION Discontinued - EQ 1MG BASE/ML (EQ 1MG BASE/ML) INJECTABLE INJECTION Discontinued - - KYTRILRLDROCHENDA 0212382001
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2MG BASE/10ML SOLUTION ORAL Discontinued - - KYTRILRLDROCHENDA 02030519952 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE **Federal Register determination that product was not withdrawn or discontinued for safety or effectiveness reasons** TABLET ORAL Discontinued - EQ 2MG BASE **Federal Register determination that product was not withdrawn or discontinued for safety or effectiveness reasons** TABLET ORAL Discontinued -
Generic (ANDA) products (48)
Abbreviated applications
- GRANISETRON HYDROCHLORIDEINTRA SANA LABSANDA 2192822025
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2MG BASE/10ML SOLUTION ORAL Rx - - GRANISETRON HYDROCHLORIDEYUNG SHIN PHARMANDA 20264820202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE/ML (EQ 1MG BASE/ML) INJECTABLE INJECTION Discontinued - EQ 4MG BASE/4ML (EQ 1MG BASE/ML) INJECTABLE INJECTION Discontinued - - GRANISETRON HYDROCHLORIDEYUNG SHIN PHARMANDA 2026472020
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) INJECTABLE INJECTION Discontinued - - GRANISETRON HYDROCHLORIDEPHARMOBEDIENTANDA 20345420172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) INJECTABLE INJECTION Discontinued - EQ 1MG BASE/ML (EQ 1MG BASE/ML) INJECTABLE INJECTION Discontinued - - GRANISETRON HYDROCHLORIDEPHARMOBEDIENTANDA 2034532017
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) INJECTABLE INJECTION Discontinued - - GRANISETRON HYDROCHLORIDEEUGIA PHARMAANDA 20423820162 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE/ML (EQ 1MG BASE/ML) INJECTABLE INJECTION Discontinued - EQ 4MG BASE/4ML (EQ 1MG BASE/ML) INJECTABLE INJECTION Discontinued - - GRANISETRON HYDROCHLORIDEAM REGENTANDA 0912742010
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE/ML (EQ 1MG BASE/ML) INJECTABLE INJECTION Discontinued - - GRANISETRON HYDROCHLORIDETAROANDA 0908172010
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE TABLET ORAL Discontinued - - GRANISETRON HYDROCHLORIDEMYLAN ASIANDA 09113620102 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) INJECTABLE INJECTION Rx AP EQ 1MG BASE/ML (EQ 1MG BASE/ML) INJECTABLE INJECTION Rx AP - GRANISETRON HYDROCHLORIDEMYLAN ASIANDA 0911372010
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) INJECTABLE INJECTION Rx AP - GRANISETRON HYDROCHLORIDEHIKMA FARMACEUTICAANDA 07862920092 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE/ML (EQ 1MG BASE/ML) INJECTABLE INJECTION Rx AP EQ 4MG BASE/4ML (EQ 1MG BASE/ML) INJECTABLE INJECTION Rx AP - GRANISETRON HYDROCHLORIDERISINGANDA 07907820092 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE/ML (EQ 1MG BASE/ML) INJECTABLE INJECTION Rx AP EQ 4MG BASE/4ML (EQ 1MG BASE/ML) INJECTABLE INJECTION Rx AP - GRANISETRON HYDROCHLORIDEEPIC PHARMA LLCANDA 0791192009
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) INJECTABLE INJECTION Discontinued - - GRANISETRON HYDROCHLORIDENATCO PHARMAANDA 0789692009
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE TABLET ORAL Rx AB - GRANISETRON HYDROCHLORIDESANDOZANDA 0785342009
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) INJECTABLE INJECTION Rx AP - GRANISETRON HYDROCHLORIDESANDOZANDA 07853120092 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE/ML (EQ 1MG BASE/ML) INJECTABLE INJECTION Rx AP EQ 4MG BASE/4ML (EQ 1MG BASE/ML) INJECTABLE INJECTION Rx AP - GRANISETRON HYDROCHLORIDEDR REDDYS LABS LTDANDA 0788462009
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE TABLET ORAL Rx AB - GRANISETRON HYDROCHLORIDEAMNEALANDA 07825820082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE/ML (EQ 1MG BASE/ML) INJECTABLE INJECTION Rx AP EQ 4MG BASE/4ML (EQ 1MG BASE/ML) INJECTABLE INJECTION Rx AP - GRANISETRON HYDROCHLORIDEBAXTER HLTHCARE CORPANDA 07819820082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE/ML (EQ 1MG BASE/ML) INJECTABLE INJECTION Discontinued - EQ 4MG BASE/4ML (EQ 1MG BASE/ML) INJECTABLE INJECTION Discontinued - - GRANISETRON HYDROCHLORIDEBIONPHARMAANDA 07886320082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) INJECTABLE INJECTION Rx AP EQ 1MG BASE/ML (EQ 1MG BASE/ML) INJECTABLE INJECTION Rx AP - GRANISETRON HYDROCHLORIDEBIONPHARMAANDA 0788802008
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) INJECTABLE INJECTION Rx AP - GRANISETRON HYDROCHLORIDERSDR REDDYSANDA 0772972008
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) INJECTABLE INJECTION Rx AP - GRANISETRON HYDROCHLORIDEFRESENIUS KABI USAANDA 0780902008
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) INJECTABLE INJECTION Rx AP - GRANISETRON HYDROCHLORIDEHIKMAANDA 0771862008
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) INJECTABLE INJECTION Rx AP - GRANISETRON HYDROCHLORIDEHIKMAANDA 0771872008
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE/ML (EQ 1MG BASE/ML) INJECTABLE INJECTION Rx AP - GRANISETRON HYDROCHLORIDESANDOZ INCANDA 07883520082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE/ML (EQ 1MG BASE/ML) INJECTABLE INJECTION Rx AP EQ 4MG BASE/4ML (EQ 1MG BASE/ML) INJECTABLE INJECTION Rx AP - GRANISETRON HYDROCHLORIDEWOCKHARDT USAANDA 0785642008
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE/ML (EQ 1MG BASE/ML) INJECTABLE INJECTION Discontinued - - GRANISETRON HYDROCHLORIDEWOCKHARDT USAANDA 0785652008
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) INJECTABLE INJECTION Discontinued - - FRESENIUS KABI USAANDA 0780962008
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE/ML (EQ 1MG BASE/ML) INJECTABLE INJECTION Rx AP - GRANISETRON HYDROCHLORIDEHIKMAANDA 0779132008
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) INJECTABLE INJECTION Rx AP - GRANISETRON HYDROCHLORIDESANDOZANDA 0788082008
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) INJECTABLE INJECTION Discontinued - - GRANISETRON HYDROCHLORIDEWOCKHARDT USAANDA 0785662008
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) INJECTABLE INJECTION Discontinued - - INTRA SANA LABSANDA 0783342008
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2MG BASE/10ML SOLUTION ORAL Discontinued - - GRANISETRON HYDROCHLORIDEAPOTEX INCANDA 0788432008
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE TABLET ORAL Discontinued - - GRANISETRON HYDROCHLORIDECHARTWELL MOLECULARANDA 0780372008
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE TABLET ORAL Rx AB - GRANISETRON HYDROCHLORIDERSORBION PHARMSANDA 0786782008
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE TABLET ORAL Rx AB - GRANISETRON HYDROCHLORIDEAUROBINDO PHARMA USAANDA 0787252008
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE TABLET ORAL Discontinued - - GRANISETRON HYDROCHLORIDETEVA PHARMS USAANDA 0779632008
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE/ML (EQ 1MG BASE/ML) INJECTABLE INJECTION Discontinued - - GRANISETRON HYDROCHLORIDEAMNEALANDA 0782622007
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) INJECTABLE INJECTION Rx AP - GRANISETRON HYDROCHLORIDEBAXTER HLTHCARE CORPANDA 0781972007
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) INJECTABLE INJECTION Discontinued - - GRANISETRON HYDROCHLORIDERSDR REDDYSANDA 0783922007
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) INJECTABLE INJECTION Rx AP - GRANISETRON HYDROCHLORIDEFRESENIUS KABI USAANDA 0785222007
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) INJECTABLE INJECTION Rx AP - GRANISETRON HYDROCHLORIDEHIKMAANDA 0771772007
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) INJECTABLE INJECTION Rx AP - DR REDDYSANDA 0771652007
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE/ML (EQ 1MG BASE/ML) INJECTABLE INJECTION Discontinued - - GRANISETRON HYDROCHLORIDEBARRANDA 0782212007
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE TABLET ORAL Discontinued - - GRANISETRON HYDROCHLORIDEEPIC PHARMA LLCANDA 0782602007
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE TABLET ORAL Discontinued - - GRANISETRON HYDROCHLORIDEHIKMAANDA 0778422007
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE TABLET ORAL Discontinued - - GRANISETRON HYDROCHLORIDETEVA PHARMSANDA 0780802007
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE TABLET ORAL Discontinued -
Listed patents
Orange Book patent file
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.
Approval history
FDA approval span
First approval
33 yr 4 mo ago
Most recent approval
1 yr 8 mo ago
Approvals span 1993–2025 across 51 FDA applications.
Brand (NDA) 36%
Generic (ANDA) 4894%
Granisetron hydrochloride: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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