FDA — authorised 27 May 1960
- Application: NDA011702
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Status: approved
🇺🇸 NSAIDs "ibubrofen,Aspirin" in United States
FDA authorised NSAIDs "ibubrofen,Aspirin" on 27 May 1960
Marketing authorisations
FDA — authorised 12 September 1960
- Application: NDA012365
- Marketing authorisation holder: MEDA PHARMS
- Status: supplemented
FDA — authorised 14 April 1978
- Application: ANDA083077
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Status: approved
FDA — authorised 9 March 1989
- Application: ANDA085732
- Marketing authorisation holder: WATSON LABS
- Indication: Labeling
- Status: approved
FDA — authorised 15 September 1992
- Application: NDA010996
- Marketing authorisation holder: XANODYNE PHARM
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 27 November 1996
- Application: ANDA074817
- Marketing authorisation holder: CHARTWELL RX
- Status: supplemented
FDA — authorised 27 February 1998
- Application: ANDA040255
- Marketing authorisation holder: ANI PHARMS
- Status: supplemented
FDA — authorised 29 May 1998
- Application: ANDA075141
- Marketing authorisation holder: GALT PHARMS
- Status: supplemented
FDA — authorised 20 December 2001
- Application: ANDA089025
- Marketing authorisation holder: TEVA
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 29 August 2023
- Application: ANDA204552
- Marketing authorisation holder: CHARTWELL MOLECULAR
- Indication: Labeling
- Status: approved
NSAIDs "ibubrofen,Aspirin" in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is NSAIDs "ibubrofen,Aspirin" approved in United States?
Yes. FDA authorised it on 27 May 1960; FDA authorised it on 12 September 1960; FDA authorised it on 14 April 1978.
Who is the marketing authorisation holder for NSAIDs "ibubrofen,Aspirin" in United States?
SUN PHARM INDUSTRIES holds the US marketing authorisation.