FDA — authorised 6 November 1964
- Application: NDA014684
- Marketing authorisation holder: LILLY
- Local brand name: AVENTYL HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Aventyl in United States
FDA authorised Aventyl on 6 November 1964
Marketing authorisations
FDA — authorised 6 November 1964
- Application: NDA014685
- Marketing authorisation holder: RANBAXY
- Local brand name: AVENTYL
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 30 March 1992
- Application: ANDA073556
- Marketing authorisation holder: DR REDDYS LABS SA
- Local brand name: NORTRIPTYLINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 31 December 1992
- Application: ANDA074054
- Marketing authorisation holder: ANI PHARMS
- Local brand name: NORTRIPTYLINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 26 July 1993
- Application: ANDA074234
- Marketing authorisation holder: RISING
- Local brand name: NORTRIPTYLINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 15 April 1994
- Application: NDA018013
- Marketing authorisation holder: SPECGX LLC
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 11 April 1996
- Application: ANDA073667
- Marketing authorisation holder: TEVA
- Local brand name: NORTRIPTYLINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 30 June 1997
- Application: ANDA074835
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: NORTRIPTYLINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 8 May 2000
- Application: ANDA075520
- Marketing authorisation holder: TARO
- Local brand name: NORTRIPTYLINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 23 August 2000
- Application: ANDA075606
- Marketing authorisation holder: PHARM ASSOC
- Local brand name: NORTRIPTYLINE HYDROCHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 20 February 2002
- Application: ANDA074132
- Marketing authorisation holder: TEVA
- Indication: Labeling
- Status: approved
FDA — authorised 20 June 2006
- Application: ANDA077965
- Marketing authorisation holder: TARO
- Local brand name: NORTRIPTYLINE HYDROCHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 24 February 2021
- Application: ANDA213441
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Status: approved
FDA — authorised 15 August 2023
- Application: ANDA217731
- Marketing authorisation holder: RUBICON RESEARCH
- Local brand name: NORTRIPTYLINE HYDROCHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
Aventyl 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 Aventyl approved in United States?
Yes. FDA authorised it on 6 November 1964; FDA authorised it on 6 November 1964; FDA authorised it on 30 March 1992.
Who is the marketing authorisation holder for Aventyl in United States?
LILLY holds the US marketing authorisation.