FDA — authorised 7 March 1951
- Application: NDA007794
- Marketing authorisation holder: TEVA
- Local brand name: NEOTHYLLINE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 DYPHYLLINE in United States
FDA authorised DYPHYLLINE on 7 March 1951 · 86 US adverse-event reports
Marketing authorisations
FDA — authorised 16 August 1976
- Application: ANDA084566
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: LUFYLLIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 August 1976
- Application: ANDA084514
- Marketing authorisation holder: SAVAGE LABS
- Local brand name: DILOR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 August 1976
- Application: ANDA084751
- Marketing authorisation holder: SAVAGE LABS
- Local brand name: DILOR-400
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 86
Most-reported reactions
- Dyspnoea — 10 reports (11.63%)
- Anxiety — 9 reports (10.47%)
- Chest Pain — 9 reports (10.47%)
- Overdose — 9 reports (10.47%)
- Pain — 9 reports (10.47%)
- Pneumonia — 9 reports (10.47%)
- Dizziness — 8 reports (9.3%)
- Drug Ineffective — 8 reports (9.3%)
- Nausea — 8 reports (9.3%)
- Hypersensitivity — 7 reports (8.14%)
DYPHYLLINE 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 DYPHYLLINE approved in United States?
Yes. FDA authorised it on 7 March 1951; FDA authorised it on 16 August 1976; FDA authorised it on 16 August 1976.
Who is the marketing authorisation holder for DYPHYLLINE in United States?
TEVA holds the US marketing authorisation.