🇺🇸 Treatment 5 in United States

FDA authorised Treatment 5 on 24 August 2004 · 11 US adverse-event reports

Marketing authorisation

FDA — authorised 24 August 2004

• Application: ANDA076239
• Marketing authorisation holder: PURE SOURCE
• Status: supplemented

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: 11

Most-reported reactions

1. Erythema — 2 reports (18.18%)
2. Application Site Erythema — 1 report (9.09%)
3. Application Site Irritation — 1 report (9.09%)
4. Application Site Pruritus — 1 report (9.09%)
5. Application Site Swelling — 1 report (9.09%)
6. Burning Sensation — 1 report (9.09%)
7. Burns First Degree — 1 report (9.09%)
8. Chemical Injury — 1 report (9.09%)
9. Contusion — 1 report (9.09%)
10. Hypersensitivity — 1 report (9.09%)

Source database →

Frequently asked questions

Is Treatment 5 approved in United States?

Yes. FDA authorised it on 24 August 2004.

Who is the marketing authorisation holder for Treatment 5 in United States?

PURE SOURCE holds the US marketing authorisation.