FDA — authorised 5 June 1989
- Marketing authorisation holder: SOMERSET
- Status: approved
🇺🇸 Selegiline Hydrochloride in United States
FDA authorised Selegiline Hydrochloride on 5 June 1989
Marketing authorisations
FDA — authorised 5 June 1989
- Application: NDA019334
- Marketing authorisation holder: QUAGEN
- Local brand name: SELEGILINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 May 1996
- Application: NDA020647
- Marketing authorisation holder: QUAGEN
- Local brand name: ELDEPRYL
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 2 August 1996
- Application: ANDA074537
- Marketing authorisation holder: G AND W LABS INC
- Local brand name: SELEGILINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 August 1996
- Application: ANDA074565
- Marketing authorisation holder: CHARTWELL MOLECULES
- Local brand name: SELEGILINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 August 1996
- Application: ANDA074641
- Marketing authorisation holder: CHARTWELL MOLECULES
- Local brand name: SELEGILINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 April 1997
- Application: ANDA074672
- Marketing authorisation holder: I3 PHARMS
- Local brand name: SELEGILINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 June 1997
- Application: ANDA074871
- Marketing authorisation holder: APOTEX
- Local brand name: SELEGILINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 November 1997
- Application: ANDA074866
- Marketing authorisation holder: NOVITIUM PHARMA
- Local brand name: SELEGILINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 April 1998
- Application: ANDA074912
- Marketing authorisation holder: KENTON
- Local brand name: SELEGILINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 September 2003
- Application: ANDA075145
- Marketing authorisation holder: LANNETT CO INC
- Local brand name: SELEGILINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 27 February 2006
- Application: NDA021336
- Marketing authorisation holder: SOMERSET
- Indication: Type 3 - New Dosage Form
- Status: approved
FDA — authorised 31 December 2008
- Application: NDA021479
- Marketing authorisation holder: BAUSCH
- Indication: Labeling
- Status: approved
FDA — authorised 2 April 2019
- Application: ANDA206803
- Marketing authorisation holder: RISING
- Local brand name: SELEGILINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
Selegiline Hydrochloride 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 Selegiline Hydrochloride approved in United States?
Yes. FDA authorised it on 5 June 1989; FDA authorised it on 5 June 1989; FDA authorised it on 15 May 1996.
Who is the marketing authorisation holder for Selegiline Hydrochloride in United States?
SOMERSET holds the US marketing authorisation.