FDA — authorised 26 September 1989
- Marketing authorisation holder: NOVARTIS
- Status: approved
🇺🇸 Clozaril in United States
FDA authorised Clozaril on 26 September 1989
Marketing authorisations
FDA — authorised 26 September 1989
- Application: NDA019758
- Marketing authorisation holder: HERITAGE LIFE
- Local brand name: CLOZARIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 November 1997
- Application: ANDA074949
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: CLOZAPINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 April 2005
- Application: ANDA075162
- Marketing authorisation holder: PAR PHARM
- Local brand name: CLOZAPINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 December 2005
- Application: ANDA076809
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: CLOZAPINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 September 2015
- Application: NDA203479
- Marketing authorisation holder: DOUGLAS PHARMS
- Indication: Labeling
- Status: approved
FDA — authorised 15 September 2015
- Application: ANDA201824
- Marketing authorisation holder: MYLAN
- Local brand name: CLOZAPINE
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 25 November 2015
- Application: ANDA202873
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: CLOZAPINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 November 2016
- Application: ANDA206433
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: CLOZAPINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 April 2021
- Application: ANDA090308
- Marketing authorisation holder: BARR LABS INC
- Indication: Labeling
- Status: approved
FDA — authorised 9 May 2025
- Application: ANDA212923
- Marketing authorisation holder: AUROBINDO PHARMA
- Indication: Labeling
- Status: approved
Aurobindo Pharma has been granted marketing authorisation by the FDA for Clozaril. The approval was issued on May 9, 2025, under application number ANDA212923. The indication approved is for the drug's labeling, but the specific local brand name is not reported.
Clozaril 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 Clozaril approved in United States?
Yes. FDA authorised it on 26 September 1989; FDA authorised it on 26 September 1989; FDA authorised it on 26 November 1997.
Who is the marketing authorisation holder for Clozaril in United States?
NOVARTIS holds the US marketing authorisation.