FDA — authorised 27 January 1975
- Application: NDA016832
- Marketing authorisation holder: ABBOTT
- Local brand name: CYLERT
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Pemolin in United States
FDA authorised Pemolin on 27 January 1975
Marketing authorisations
FDA — authorised 27 January 1975
- Status: approved
FDA — authorised 30 January 1976
- Application: NDA017703
- Marketing authorisation holder: ABBOTT
- Local brand name: CYLERT
- Indication: TABLET, CHEWABLE — ORAL
- Status: approved
FDA — authorised 29 January 1999
- Application: ANDA075030
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: PEMOLINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 June 1999
- Application: ANDA075286
- Marketing authorisation holder: FOSUN PHARMA
- Local brand name: PEMOLINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 February 2000
- Application: ANDA075555
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: PEMOLINE
- Indication: TABLET, CHEWABLE — ORAL
- Status: approved
FDA — authorised 28 February 2000
- Application: ANDA075595
- Marketing authorisation holder: ACTAVIS ELIZABETH
- Local brand name: PEMOLINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 April 2000
- Application: ANDA075328
- Marketing authorisation holder: VINTAGE PHARMS
- Local brand name: PEMOLINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 July 2000
- Application: ANDA075678
- Marketing authorisation holder: ACTAVIS ELIZABETH
- Local brand name: PEMOLINE
- Indication: TABLET, CHEWABLE — ORAL
- Status: approved
FDA — authorised 18 September 2000
- Application: ANDA075287
- Marketing authorisation holder: WATSON LABS
- Local brand name: PEMOLINE
- Indication: TABLET — ORAL
- Status: approved
Pemolin 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 Pemolin approved in United States?
Yes. FDA authorised it on 27 January 1975; FDA authorised it on 27 January 1975; FDA authorised it on 30 January 1976.
Who is the marketing authorisation holder for Pemolin in United States?
ABBOTT holds the US marketing authorisation.