FDA — authorised 28 July 1988
- Application: NDA019201
- Marketing authorisation holder: NOVARTIS
- Local brand name: VOLTAREN
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
🇺🇸 DIC075V in United States
FDA authorised DIC075V on 28 July 1988
Marketing authorisations
FDA — authorised 28 March 1991
- Application: NDA020037
- Marketing authorisation holder: NOVARTIS
- Local brand name: VOLTAREN
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 24 November 1993
- Application: NDA020142
- Marketing authorisation holder: NOVARTIS
- Local brand name: CATAFLAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 March 2004
- Application: ANDA076561
- Marketing authorisation holder: AMICI PHARMA
- Local brand name: CATAFLAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 June 2009
- Application: NDA022202
- Marketing authorisation holder: ASSERTIO SPECLTY
- Local brand name: ZIPSOR
- Indication: CAPSULE — ORAL
- Status: approved
Frequently asked questions
Is DIC075V approved in United States?
Yes. FDA authorised it on 28 July 1988; FDA authorised it on 28 March 1991; FDA authorised it on 24 November 1993.
Who is the marketing authorisation holder for DIC075V in United States?
NOVARTIS holds the US marketing authorisation.