FDA — authorised 29 January 2002
- Application: ANDA075662
- Marketing authorisation holder: WATSON LABS
- Local brand name: FLUOXETINE
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Combination Drug Therapy in United States
FDA authorised Combination Drug Therapy on 29 January 2002 · 3 US adverse-event reports
Marketing authorisations
FDA — authorised 29 January 2002
- Application: ANDA075787
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: FLUOXETINE
- Indication: CAPSULE — ORAL
- 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: 22 April 2025 – 22 April 2026
- Total reports: 3
Most-reported reactions
- Agitation — 1 report (33.33%)
- Catatonia — 1 report (33.33%)
- Tardive Dyskinesia — 1 report (33.33%)
Frequently asked questions
Is Combination Drug Therapy approved in United States?
Yes. FDA authorised it on 29 January 2002; FDA authorised it on 29 January 2002.
Who is the marketing authorisation holder for Combination Drug Therapy in United States?
WATSON LABS holds the US marketing authorisation.