FDA — authorised 29 December 1993
- Application: NDA020239
- Marketing authorisation holder: ROCHE
- Local brand name: KYTRIL
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 GRANISETRON HYDROCHLORIDE in United States
FDA authorised GRANISETRON HYDROCHLORIDE on 29 December 1993
Marketing authorisations
FDA — authorised 16 March 1995
- Application: NDA020305
- Marketing authorisation holder: ROCHE
- Local brand name: KYTRIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 June 2001
- Application: NDA021238
- Marketing authorisation holder: ROCHE
- Local brand name: KYTRIL
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 31 December 2007
- Application: ANDA077177
- Marketing authorisation holder: HIKMA
- Local brand name: GRANISETRON HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 31 December 2007
- Application: ANDA078080
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: GRANISETRON HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 December 2007
- Application: ANDA078221
- Marketing authorisation holder: BARR
- Local brand name: GRANISETRON HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 December 2007
- Application: ANDA078522
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: GRANISETRON HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 31 December 2007
- Application: ANDA078262
- Marketing authorisation holder: AMNEAL
- Local brand name: GRANISETRON HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 31 December 2007
- Application: ANDA077165
- Marketing authorisation holder: DR REDDYS
- Local brand name: GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 31 December 2007
- Application: ANDA078260
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: GRANISETRON HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 December 2007
- Application: ANDA078392
- Marketing authorisation holder: DR REDDYS
- Local brand name: GRANISETRON HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 31 December 2007
- Application: ANDA077842
- Marketing authorisation holder: HIKMA
- Local brand name: GRANISETRON HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 January 2008
- Application: ANDA077963
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: GRANISETRON HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 January 2008
- Application: ANDA078725
- Marketing authorisation holder: AUROBINDO PHARMA USA
- Local brand name: GRANISETRON HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 February 2008
- Application: ANDA078678
- Marketing authorisation holder: ORBION PHARMS
- Local brand name: GRANISETRON HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 February 2008
- Application: ANDA078843
- Marketing authorisation holder: APOTEX INC
- Local brand name: GRANISETRON HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 February 2008
- Application: ANDA078037
- Marketing authorisation holder: CHARTWELL MOLECULAR
- Local brand name: GRANISETRON HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 February 2008
- Application: ANDA078334
- Marketing authorisation holder: INTRA SANA LABS
- Local brand name: GRANISOL
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 29 February 2008
- Application: ANDA078566
- Marketing authorisation holder: WOCKHARDT USA
- Local brand name: GRANISETRON HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 April 2008
- Application: ANDA078808
- Marketing authorisation holder: SANDOZ
- Local brand name: GRANISETRON HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 26 June 2008
- Application: ANDA077913
- Marketing authorisation holder: HIKMA
- Local brand name: GRANISETRON HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 June 2008
- Application: ANDA078258
- Marketing authorisation holder: AMNEAL
- Local brand name: GRANISETRON HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 June 2008
- Application: ANDA078096
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 June 2008
- Application: ANDA078564
- Marketing authorisation holder: WOCKHARDT USA
- Local brand name: GRANISETRON HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 June 2008
- Application: ANDA078835
- Marketing authorisation holder: SANDOZ INC
- Local brand name: GRANISETRON HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 June 2008
- Application: ANDA078565
- Marketing authorisation holder: WOCKHARDT USA
- Local brand name: GRANISETRON HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 June 2008
- Application: ANDA078090
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: GRANISETRON HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 June 2008
- Application: ANDA078880
- Marketing authorisation holder: BIONPHARMA
- Local brand name: GRANISETRON HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 June 2008
- Application: ANDA077187
- Marketing authorisation holder: HIKMA
- Local brand name: GRANISETRON HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 June 2008
- Application: ANDA077186
- Marketing authorisation holder: HIKMA
- Local brand name: GRANISETRON HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 June 2008
- Application: ANDA078863
- Marketing authorisation holder: BIONPHARMA
- Local brand name: GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 February 2009
- Application: ANDA078846
- Marketing authorisation holder: DR REDDYS LABS LTD
- Local brand name: GRANISETRON HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 April 2009
- Application: ANDA078531
- Marketing authorisation holder: SANDOZ
- Local brand name: GRANISETRON HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 April 2009
- Application: ANDA078534
- Marketing authorisation holder: SANDOZ
- Local brand name: GRANISETRON HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 22 June 2009
- Application: ANDA078969
- Marketing authorisation holder: NATCO PHARMA
- Local brand name: GRANISETRON HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 September 2009
- Application: ANDA079119
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: GRANISETRON HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 23 December 2009
- Application: ANDA078629
- Marketing authorisation holder: HIKMA FARMACEUTICA
- Local brand name: GRANISETRON HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 9 April 2010
- Application: ANDA091136
- Marketing authorisation holder: MYLAN ASI
- Local brand name: GRANISETRON HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 9 April 2010
- Application: ANDA091137
- Marketing authorisation holder: MYLAN ASI
- Local brand name: GRANISETRON HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 May 2010
- Application: ANDA090817
- Marketing authorisation holder: TARO
- Local brand name: GRANISETRON HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 September 2010
- Application: ANDA091274
- Marketing authorisation holder: AM REGENT
- Local brand name: GRANISETRON HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 6 July 2016
- Application: ANDA204238
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: GRANISETRON HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 31 January 2017
- Application: ANDA203453
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: GRANISETRON HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 4 April 2017
- Application: ANDA203454
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: GRANISETRON HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 6 March 2020
- Application: ANDA202647
- Marketing authorisation holder: YUNG SHIN PHARM
- Local brand name: GRANISETRON HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 June 2020
- Application: ANDA202648
- Marketing authorisation holder: YUNG SHIN PHARM
- Local brand name: GRANISETRON HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 17 March 2025
- Application: ANDA219282
- Marketing authorisation holder: INTRA SANA LABS
- Local brand name: GRANISETRON HYDROCHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA
- Status: approved
GRANISETRON HYDROCHLORIDE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is GRANISETRON HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 29 December 1993; FDA authorised it on 16 March 1995; FDA authorised it on 27 June 2001.
Who is the marketing authorisation holder for GRANISETRON HYDROCHLORIDE in United States?
ROCHE holds the US marketing authorisation.