FDA — authorised 3 August 2004
- Application: NDA021427
- Marketing authorisation holder: LILLY
- Local brand name: CYMBALTA
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
🇺🇸 Cymbalta in United States
FDA authorised Cymbalta on 3 August 2004
Marketing authorisations
FDA — authorised 3 September 2004
- Application: NDA021733
- Marketing authorisation holder: LILLY
- Local brand name: CYMBALTA
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA — authorised 13 June 2008
- Application: NDA022148
- Marketing authorisation holder: LILLY
- Local brand name: CYMBALTA
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA — authorised 11 December 2013
- Application: ANDA090723
- Marketing authorisation holder: ADAPTIS
- Status: approved
FDA — authorised 11 December 2013
- Application: ANDA090694
- Marketing authorisation holder: LUPIN LTD
- Status: approved
FDA — authorised 28 October 2015
- Application: ANDA202336
- Marketing authorisation holder: INVENTIA
- Status: approved
FDA — authorised 22 December 2015
- Application: ANDA203088
- Marketing authorisation holder: BRECKENRIDGE
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 2 May 2023
- Application: ANDA210599
- Marketing authorisation holder: QINGDAO BAHEAL PHARM
- Indication: Labeling
- Status: approved
Cymbalta in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Cymbalta approved in United States?
Yes. FDA authorised it on 3 August 2004; FDA authorised it on 3 September 2004; FDA authorised it on 13 June 2008.
Who is the marketing authorisation holder for Cymbalta in United States?
LILLY holds the US marketing authorisation.