FDA — authorised 29 December 1993
- Application: NDA020272
- Marketing authorisation holder: JANSSEN PHARMS
- Local brand name: RISPERDAL
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Risperdal in United States
FDA authorised Risperdal 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 29 October 2003
- Application: NDA021346
- Marketing authorisation holder: JANSSEN PHARMS
- Local brand name: RISPERDAL CONSTA
- Indication: POWDER — INTRAMUSCULAR
- 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: ANDA076288
- Marketing authorisation holder: NATCO PHARMA USA
- 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 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: ANDA077769
- Marketing authorisation holder: HERITAGE PHARMA AVET
- 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 24 October 2008
- Application: ANDA076879
- Marketing authorisation holder: DR REDDYS LABS LTD
- 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 1 May 2009
- Application: ANDA078516
- Marketing authorisation holder: ZYDUS PHARMS USA
- Local brand name: RISPERIDONE
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 17 June 2009
- Application: ANDA078071
- Marketing authorisation holder: AMNEAL
- Local brand name: RISPERIDONE
- Indication: TABLET — ORAL
- Status: approved
The FDA approved Risperdal, manufactured by AMNEAL, on 13 August 2025. This approval was granted under the standard expedited pathway. The approved indication for Risperdal is listed as 'Labeling', indicating that the product is approved for the uses and indications described in its labelling.
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: ANDA077719
- Marketing authorisation holder: PHARM ASSOC
- 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 26 October 2009
- Application: ANDA077494
- Marketing authorisation holder: PH HEALTH
- Indication: Manufacturing (CMC)
- 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 3 December 2010
- Application: ANDA079158
- Marketing authorisation holder: LANNETT CO INC
- 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 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 October 2012
- Application: ANDA077542
- Marketing authorisation holder: SUN PHARM INDS LTD
- Indication: Labeling
- 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 26 January 2017
- Application: ANDA077493
- Marketing authorisation holder: PRINSTON INC
- Indication: Labeling
- 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 5 March 2024
- Application: ANDA077543
- Marketing authorisation holder: CHARTWELL MOLECULAR
- Indication: Labeling
- Status: approved
The FDA approved Risperdal for labeling indications on 2024-03-05. The marketing authorisation holder is CHARTWELL MOLECULAR. This approval was granted under the standard expedited pathway.
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
- Application: ANDA077416
- Marketing authorisation holder: RANBAXY
- Local brand name: RISPERIDONE
- Indication: SOLUTION — ORAL
- Status: approved
Risperdal in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is Risperdal 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 Risperdal in United States?
JANSSEN PHARMS holds the US marketing authorisation.