FDA — authorised 30 August 2002
- Application: ANDA075478
- Marketing authorisation holder: BARR
- Indication: Labeling
- Status: approved
🇺🇸 "3D" regimen in United States
FDA authorised "3D" regimen on 30 August 2002 · 4,044,851 US adverse-event reports
Marketing authorisations
FDA — authorised 24 February 2004
- Application: ANDA076455
- Marketing authorisation holder: DURAMED PHARMS BARR
- Indication: Labeling
- Status: approved
FDA — authorised 19 October 2015
- Application: ANDA203777
- Marketing authorisation holder: 3D IMAGING DRUG
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 19 October 2015
- Application: ANDA203779
- Marketing authorisation holder: 3D IMAGING DRUG
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 30 October 2015
- Application: ANDA203778
- Marketing authorisation holder: 3D IMAGING DRUG
- 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: 4,044,851
Most-reported reactions
- Drug Ineffective — 602,695 reports (14.9%)
- Off Label Use — 484,691 reports (11.98%)
- Fatigue — 471,293 reports (11.65%)
- Nausea — 440,108 reports (10.88%)
- Diarrhoea — 384,483 reports (9.51%)
- Pain — 371,812 reports (9.19%)
- Headache — 351,348 reports (8.69%)
- Death — 341,390 reports (8.44%)
- Dyspnoea — 320,896 reports (7.93%)
- Dizziness — 276,135 reports (6.83%)
"3D" regimen 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 "3D" regimen approved in United States?
Yes. FDA authorised it on 30 August 2002; FDA authorised it on 24 February 2004; FDA authorised it on 19 October 2015.
Who is the marketing authorisation holder for "3D" regimen in United States?
BARR holds the US marketing authorisation.