FDA — authorised 29 December 1993
- Application: NDA020272
- Marketing authorisation holder: JANSSEN PHARMS
- Local brand name: RISPERDAL
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 RBP-7000 in United States
FDA authorised RBP-7000 on 29 December 1993
Marketing authorisations
FDA — authorised 10 June 1996
- Application: NDA020588
- Marketing authorisation holder: JANSSEN PHARMS
- Local brand name: RISPERDAL
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 2 April 2003
- Application: NDA021444
- Marketing authorisation holder: JANSSEN PHARMS
- Local brand name: RISPERDAL
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 30 June 2008
- Application: ANDA076228
- Marketing authorisation holder: HERITAGE PHARMA AVET
- Local brand name: RISPERIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 September 2008
- Application: ANDA077953
- Marketing authorisation holder: APOTEX INC
- Local brand name: RISPERIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 September 2008
- Application: ANDA076288
- Marketing authorisation holder: NATCO PHARMA USA
- Local brand name: RISPERIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 October 2008
- Application: ANDA078269
- Marketing authorisation holder: RISING
- Local brand name: RISPERIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 October 2008
- Application: ANDA078871
- Marketing authorisation holder: NOVITIUM PHARMA
- Local brand name: RISPERIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 October 2008
- Application: ANDA078040
- Marketing authorisation holder: ZYDUS PHARMS USA INC
- Local brand name: RISPERIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 October 2008
- Application: ANDA077769
- Marketing authorisation holder: HERITAGE PHARMA AVET
- Local brand name: RISPERIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 October 2008
- Application: ANDA076879
- Marketing authorisation holder: DR REDDYS LABS LTD
- Local brand name: RISPERIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 December 2008
- Application: ANDA077860
- Marketing authorisation holder: WATSON LABS
- Local brand name: RISPERIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 December 2008
- Application: ANDA078707
- Marketing authorisation holder: RENATA
- Local brand name: RISPERIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 February 2009
- Application: ANDA077328
- Marketing authorisation holder: SENORES PHARMS
- Local brand name: RISPERIDONE
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 23 March 2009
- Application: ANDA078828
- Marketing authorisation holder: JUBILANT CADISTA
- Local brand name: RISPERIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 April 2009
- Application: ANDA077494
- Marketing authorisation holder: PH HEALTH
- Local brand name: RISPERIDONE
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 1 May 2009
- Application: ANDA078516
- Marketing authorisation holder: ZYDUS PHARMS USA
- Local brand name: RISPERIDONE
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 29 May 2009
- Application: ANDA078740
- Marketing authorisation holder: WEST WARD PHARMS
- Local brand name: RISPERIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 June 2009
- Application: ANDA078071
- Marketing authorisation holder: AMNEAL
- Local brand name: RISPERIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 July 2009
- Application: ANDA078909
- Marketing authorisation holder: APOZEAL PHARMS
- Local brand name: RISPERIDONE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 29 July 2009
- Application: ANDA076904
- Marketing authorisation holder: HIKMA
- Local brand name: RISPERIDONE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 29 July 2009
- Application: ANDA077719
- Marketing authorisation holder: PHARM ASSOC
- Local brand name: RISPERIDONE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 4 September 2009
- Application: ANDA078452
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: RISPERIDONE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 8 October 2009
- Application: ANDA078744
- Marketing authorisation holder: WOCKHARDT BIO AG
- Local brand name: RISPERIDONE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 16 October 2009
- Application: ANDA078528
- Marketing authorisation holder: SANDOZ
- Local brand name: RISPERIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 December 2009
- Application: ANDA078116
- Marketing authorisation holder: SANDOZ
- Local brand name: RISPERIDONE
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 8 June 2010
- Application: ANDA077784
- Marketing authorisation holder: RATIOPHARM
- Local brand name: RISPERIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 June 2010
- Application: ANDA076797
- Marketing authorisation holder: PRECISION DOSE
- Local brand name: RISPERIDONE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 6 August 2010
- Application: ANDA077542
- Marketing authorisation holder: SUN PHARM INDS LTD
- Local brand name: RISPERIDONE
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 3 December 2010
- Application: ANDA079158
- Marketing authorisation holder: LANNETT CO INC
- Local brand name: RISPERIDONE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 7 February 2011
- Application: ANDA090347
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: RISPERIDONE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 30 March 2011
- Application: ANDA091537
- Marketing authorisation holder: NATCO PHARMA USA
- Local brand name: RISPERIDONE
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 18 May 2011
- Application: ANDA077543
- Marketing authorisation holder: CHARTWELL MOLECULAR
- Local brand name: RISPERIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 August 2011
- Application: ANDA201003
- Marketing authorisation holder: AJANTA PHARMA LTD
- Local brand name: RISPERIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 November 2011
- Application: ANDA090839
- Marketing authorisation holder: JUBILANT GENERICS
- Local brand name: RISPERIDONE
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 29 November 2011
- Application: ANDA077493
- Marketing authorisation holder: PRINSTON INC
- Local brand name: RISPERIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 March 2012
- Application: ANDA076908
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: RISPERIDONE
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 12 December 2012
- Application: ANDA079059
- Marketing authorisation holder: TRIS PHARMA INC
- Local brand name: RISPERIDONE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 10 March 2014
- Application: ANDA078036
- Marketing authorisation holder: SUN PHARM INDS INC
- Local brand name: RISPERIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 January 2015
- Application: ANDA202386
- Marketing authorisation holder: CHARTWELL MOLECULAR
- Local brand name: RISPERIDONE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 27 July 2018
- Application: NDA210655
- Marketing authorisation holder: INDIVIOR
- Local brand name: PERSERIS KIT
- Indication: FOR SUSPENSION, EXTENDED RELEASE — SUBCUTANEOUS
- Status: approved
FDA — authorised 13 January 2023
- Application: NDA212849
- Marketing authorisation holder: SHANDONG LUYE
- Local brand name: RYKINDO
- Indication: FOR SUSPENSION, EXTENDED RELEASE — INTRAMUSCULAR
- Status: approved
FDA — authorised 28 April 2023
- Application: NDA213586
- Marketing authorisation holder: TEVA
- Local brand name: UZEDY
- Indication: SUSPENSION, EXTENDED RELEASE — SUBCUTANEOUS
- Status: approved
FDA — authorised 5 December 2023
- Application: ANDA214068
- Marketing authorisation holder: TEVA PHARMS USA INC
- Local brand name: RISPERIDONE
- Indication: POWDER — INTRAMUSCULAR
- Status: approved
FDA — authorised 29 March 2024
- Application: NDA214835
- Marketing authorisation holder: LABS FARMS ROVI SA
- Local brand name: RISVAN
- Indication: FOR SUSPENSION, EXTENDED RELEASE — INTRAMUSCULAR
- Status: approved
FDA — authorised 26 June 2024
- Application: ANDA205104
- Marketing authorisation holder: IPCA LABS LTD
- Local brand name: RISPERIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 September 2025
- Application: ANDA211220
- Marketing authorisation holder: NANOMI
- Local brand name: RISPERIDONE
- Indication: POWDER — INTRAMUSCULAR
- Status: approved
FDA
- Application: ANDA077416
- Marketing authorisation holder: RANBAXY
- Local brand name: RISPERIDONE
- Indication: SOLUTION — ORAL
- Status: approved
RBP-7000 in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Psychiatry approved in United States
Frequently asked questions
Is RBP-7000 approved in United States?
Yes. FDA authorised it on 29 December 1993; FDA authorised it on 10 June 1996; FDA authorised it on 2 April 2003.
Who is the marketing authorisation holder for RBP-7000 in United States?
JANSSEN PHARMS holds the US marketing authorisation.