FDA — authorised 28 March 2013
- Application: NDA204061
- Marketing authorisation holder: TEVA BRANDED PHARM
- Local brand name: QUARTETTE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 DR-103 in United States
FDA authorised DR-103 on 28 March 2013 · 1 US adverse-event reports
Marketing authorisation
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: 23 April 2025 – 23 April 2026
- Total reports: 1
Most-reported reactions
- Drug Dependence — 1 report (100%)
Other Women's Health approved in United States
Frequently asked questions
Is DR-103 approved in United States?
Yes. FDA authorised it on 28 March 2013.
Who is the marketing authorisation holder for DR-103 in United States?
TEVA BRANDED PHARM holds the US marketing authorisation.