FDA — authorised 19 April 1982
- Application: NDA018445
- Marketing authorisation holder: MERCK
- Local brand name: DOLOBID
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Dolobid in United States
FDA authorised Dolobid on 19 April 1982
Marketing authorisations
FDA — authorised 19 April 1982
- Status: approved
FDA — authorised 31 July 1992
- Application: ANDA073679
- Marketing authorisation holder: TEVA
- Local brand name: DIFLUNISAL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 July 1992
- Application: ANDA073673
- Marketing authorisation holder: TEVA
- Local brand name: DIFLUNISAL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 November 1992
- Application: ANDA073562
- Marketing authorisation holder: DASTECH INTL
- Local brand name: DIFLUNISAL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 November 1992
- Application: ANDA073563
- Marketing authorisation holder: DASTECH INTL
- Local brand name: DIFLUNISAL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 May 1996
- Application: ANDA074285
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: DIFLUNISAL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 June 1996
- Application: ANDA074604
- Marketing authorisation holder: ANI PHARMS
- Local brand name: DIFLUNISAL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 July 1997
- Application: ANDA074400
- Marketing authorisation holder: WATSON LABS
- Local brand name: DIFLUNISAL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 March 2012
- Application: ANDA202845
- Marketing authorisation holder: HERITAGE PHARMA
- Local brand name: DIFLUNISAL
- Indication: TABLET — ORAL
- Status: approved
The FDA approved the marketing authorisation for Dolobid on 16 August 2024. This approval was granted to HERITAGE PHARMA under the standard expedited pathway for manufacturing (CMC) purposes. The application number for this approval is ANDA202845.
FDA — authorised 16 June 2017
- Application: ANDA203547
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: DIFLUNISAL
- Indication: TABLET — ORAL
- Status: approved
Dolobid 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 Dolobid approved in United States?
Yes. FDA authorised it on 19 April 1982; FDA authorised it on 19 April 1982; FDA authorised it on 31 July 1992.
Who is the marketing authorisation holder for Dolobid in United States?
MERCK holds the US marketing authorisation.