FDA — authorised 11 December 2013
- Application: ANDA090778
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: DULOXETINE HYDROCHLORIDE
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
🇺🇸 Drug treatment with Cymbalta in United States
FDA authorised Drug treatment with Cymbalta on 11 December 2013
Marketing authorisations
FDA — authorised 11 December 2013
- Application: ANDA090774
- Marketing authorisation holder: TORRENT
- Local brand name: DULOXETINE HYDROCHLORIDE
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA — authorised 11 December 2013
- Application: ANDA090783
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: DULOXETINE HYDROCHLORIDE
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA — authorised 17 December 2013
- Application: ANDA090776
- Marketing authorisation holder: ACTAVIS ELIZABETH
- Local brand name: DULOXETINE HYDROCHLORIDE
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA — authorised 9 June 2014
- Application: ANDA202949
- Marketing authorisation holder: ALEMBIC
- Local brand name: DULOXETINE HYDROCHLORIDE
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA — authorised 26 August 2015
- Application: ANDA203197
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: DULOXETINE HYDROCHLORIDE
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA — authorised 28 October 2015
- Application: ANDA090780
- Marketing authorisation holder: PH HEALTH
- Local brand name: DULOXETINE HYDROCHLORIDE
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA — authorised 3 August 2016
- Application: ANDA204343
- Marketing authorisation holder: HETERO LABS LTD III
- Local brand name: DULOXETINE HYDROCHLORIDE
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA — authorised 6 January 2017
- Application: ANDA208706
- Marketing authorisation holder: AJANTA PHARMA LTD
- Local brand name: DULOXETINE HYDROCHLORIDE
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA — authorised 23 March 2017
- Application: ANDA204815
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: DULOXETINE HYDROCHLORIDE
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA — authorised 16 August 2019
- Application: ANDA207219
- Marketing authorisation holder: YAOPHARMA CO LTD
- Local brand name: DULOXETINE HYDROCHLORIDE
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA
- Application: ANDA090775
- Marketing authorisation holder: SANDOZ
- Local brand name: DULOXETINE HYDROCHLORIDE
- Indication: CAPSULE, DELAYED RELEASE — ORAL
- Status: approved
FDA
- Application: ANDA090773
- Marketing authorisation holder: WOCKHARDT
- Local brand name: DULOXETINE HYDROCHLORIDE
- Indication: CAPSULE, DELAYED RELEASE — ORAL
- Status: approved
FDA
- Status: approved
Drug treatment with Cymbalta in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Drug treatment with Cymbalta approved in United States?
Yes. FDA authorised it on 11 December 2013; FDA authorised it on 11 December 2013; FDA authorised it on 11 December 2013.
Who is the marketing authorisation holder for Drug treatment with Cymbalta in United States?
AUROBINDO PHARMA LTD holds the US marketing authorisation.