FDA — authorised 5 November 1981
- Marketing authorisation holder: WARNER CHILCOTT LLC
- Status: approved
🇺🇸 Oxtriphylline in United States
FDA authorised Oxtriphylline on 5 November 1981
Marketing authorisations
FDA — authorised 5 November 1981
- Application: ANDA086742
- Marketing authorisation holder: WARNER CHILCOTT LLC
- Local brand name: CHOLEDYL SA
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 24 May 1983
- Application: ANDA087863
- Marketing authorisation holder: WARNER CHILCOTT LLC
- Local brand name: CHOLEDYL SA
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA
- Application: ANDA088243
- Marketing authorisation holder: MORTON GROVE
- Local brand name: OXTRIPHYLLINE
- Indication: SOLUTION — ORAL
- Status: approved
FDA
- Application: ANDA087866
- Marketing authorisation holder: WATSON LABS
- Local brand name: OXTRIPHYLLINE
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA
- Application: NDA009268
- Marketing authorisation holder: PARKE DAVIS
- Local brand name: CHOLEDYL
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA
- Application: ANDA088242
- Marketing authorisation holder: MORTON GROVE
- Local brand name: OXTRIPHYLLINE PEDIATRIC
- Indication: SYRUP — ORAL
- Status: approved
Oxtriphylline in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Respiratory approved in United States
Frequently asked questions
Is Oxtriphylline approved in United States?
Yes. FDA authorised it on 5 November 1981; FDA authorised it on 5 November 1981; FDA authorised it on 24 May 1983.
Who is the marketing authorisation holder for Oxtriphylline in United States?
WARNER CHILCOTT LLC holds the US marketing authorisation.