FDA — authorised 16 May 1977
- Application: NDA008319
- Marketing authorisation holder: NOVARTIS
- Local brand name: BUTAZOLIDIN
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Phenylbutazon in United States
FDA authorised Phenylbutazon on 16 May 1977
Marketing authorisations
FDA — authorised 29 October 1979
- Application: ANDA086151
- Marketing authorisation holder: WATSON LABS
- Local brand name: PHENYLBUTAZONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 January 1980
- Application: ANDA084339
- Marketing authorisation holder: FOSUN PHARMA
- Local brand name: PHENYLBUTAZONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 January 1980
- Marketing authorisation holder: SANDOZ
- Status: approved
FDA — authorised 13 October 1981
- Application: ANDA087260
- Marketing authorisation holder: SANOFI AVENTIS US
- Local brand name: AZOLID
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 21 April 1982
- Application: ANDA087674
- Marketing authorisation holder: WATSON LABS
- Local brand name: PHENYLBUTAZONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 June 1982
- Application: ANDA087774
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: PHENYLBUTAZONE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 17 December 1982
- Application: ANDA087756
- Marketing authorisation holder: WATSON LABS
- Local brand name: PHENYLBUTAZONE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 24 June 1983
- Application: ANDA088218
- Marketing authorisation holder: IVAX PHARMS
- Local brand name: PHENYLBUTAZONE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 4 December 1985
- Application: ANDA088994
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: PHENYLBUTAZONE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 4 December 1985
- Application: ANDA088863
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: PHENYLBUTAZONE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA087091
- Marketing authorisation holder: SANOFI AVENTIS US
- Local brand name: AZOLID
- Indication: TABLET — ORAL
- Status: approved
Phenylbutazon in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Pain approved in United States
Frequently asked questions
Is Phenylbutazon approved in United States?
Yes. FDA authorised it on 16 May 1977; FDA authorised it on 29 October 1979; FDA authorised it on 10 January 1980.
Who is the marketing authorisation holder for Phenylbutazon in United States?
NOVARTIS holds the US marketing authorisation.