FDA — authorised 4 June 1975
- Application: NDA017533
- Marketing authorisation holder: CHEPLAPHARM
- Local brand name: KLONOPIN
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Klonopin in United States
FDA authorised Klonopin on 4 June 1975
Marketing authorisations
FDA — authorised 10 September 1996
- Application: ANDA074569
- Marketing authorisation holder: TEVA
- Local brand name: CLONAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 October 1996
- Application: ANDA074869
- Marketing authorisation holder: ACTAVIS ELIZABETH
- Local brand name: CLONAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 August 1997
- Application: ANDA074979
- Marketing authorisation holder: SANDOZ
- Local brand name: CLONAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 September 1997
- Application: ANDA074925
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: CLONAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 October 1997
- Application: ANDA074940
- Marketing authorisation holder: QUAGEN
- Local brand name: CLONAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 December 1997
- Application: NDA020813
- Marketing authorisation holder: ROCHE
- Local brand name: KLONOPIN RAPIDLY DISINTEGRATING
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 30 December 1997
- Application: ANDA074964
- Marketing authorisation holder: WATSON LABS
- Local brand name: CLONAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 August 1998
- Application: ANDA074920
- Marketing authorisation holder: TEVA
- Local brand name: CLONAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 October 1998
- Application: ANDA075150
- Marketing authorisation holder: AUROBINDO PHARMA USA
- Local brand name: CLONAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 October 2000
- Application: ANDA075468
- Marketing authorisation holder: RUBICON RESEARCH
- Local brand name: CLONAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 May 2005
- Application: ANDA077147
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: CLONAZEPAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 August 2005
- Application: ANDA077171
- Marketing authorisation holder: PH HEALTH
- Local brand name: CLONAZEPAM
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 27 June 2010
- Application: ANDA077194
- Marketing authorisation holder: BARR
- Indication: Labeling
- Status: approved
FDA — authorised 27 August 2014
- Application: ANDA078654
- Marketing authorisation holder: SUN PHARM INDS INC
- Local brand name: CLONAZEPAM
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 10 February 2016
- Application: ANDA077856
- Marketing authorisation holder: PRINSTON INC
- Indication: Labeling
- Status: approved
FDA — authorised 28 June 2019
- Application: ANDA211033
- Marketing authorisation holder: ALEMBIC
- Local brand name: CLONAZEPAM
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
Klonopin 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 Klonopin approved in United States?
Yes. FDA authorised it on 4 June 1975; FDA authorised it on 10 September 1996; FDA authorised it on 31 October 1996.
Who is the marketing authorisation holder for Klonopin in United States?
CHEPLAPHARM holds the US marketing authorisation.