FDA — authorised 4 December 1970
- Application: NDA019853
- Marketing authorisation holder: VALEANT PHARMS INTL
- Local brand name: CUPRIMINE
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Cuprimine in United States
FDA authorised Cuprimine on 4 December 1970
Marketing authorisations
FDA — authorised 4 December 1970
- Marketing authorisation holder: ATON
- Status: approved
FDA — authorised 8 November 1978
- Application: NDA019854
- Marketing authorisation holder: MYLAN SPECIALITY LP
- Local brand name: DEPEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 December 2019
- Application: ANDA211231
- Marketing authorisation holder: PH HEALTH
- Local brand name: PENICILLAMINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 23 December 2019
- Application: ANDA211196
- Marketing authorisation holder: PH HEALTH
- Local brand name: PENICILLAMINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 February 2020
- Application: ANDA211497
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: PENICILLAMINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 April 2020
- Application: ANDA213310
- Marketing authorisation holder: APOTEX
- Local brand name: PENICILLAMINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 4 August 2020
- Application: ANDA211867
- Marketing authorisation holder: DR REDDYS
- Local brand name: PENICILLAMINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 30 November 2020
- Application: ANDA212933
- Marketing authorisation holder: LUPIN
- Local brand name: PENICILLAMINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 December 2020
- Application: ANDA211735
- Marketing authorisation holder: GRANULES
- Local brand name: PENICILLAMINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 19 August 2021
- Application: ANDA213293
- Marketing authorisation holder: INVAGEN PHARMS
- Local brand name: PENICILLAMINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 23 August 2021
- Application: ANDA215409
- Marketing authorisation holder: BRECKENRIDGE
- Local brand name: PENICILLAMINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 8 October 2021
- Application: ANDA214363
- Marketing authorisation holder: NAVINTA LLC
- Local brand name: PENICILLAMINE
- Indication: CAPSULE — ORAL
- Status: approved
Cuprimine 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 Cuprimine approved in United States?
Yes. FDA authorised it on 4 December 1970; FDA authorised it on 4 December 1970; FDA authorised it on 8 November 1978.
Who is the marketing authorisation holder for Cuprimine in United States?
VALEANT PHARMS INTL holds the US marketing authorisation.