Drugs / Zithromax
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (4) | US (FDA) | ZITHROMAX | — | 1996-11-22 – 2004-01-15 | fda.gov ↗ |
| Approved | US (FDA) | ZITHROMAX | — | 1991-11-01 | fda.gov ↗ |
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04344457 | Apr → Jun 2020 | COVID-19 | Perseverance Research Center, LLC | Unknown | No outcome recorded |
| Phase 2/31 trial · 1 missed | ||||||
| Phase 2/3 | NCT02288832 | Mar 2015 → Jul 2018 | — | Assistance Publique Hopitaux De Marseille | Completed | Missed primary |
| Phase 41 trial · 1 missed | ||||||
| Phase 4 | NCT01444469 | Sep 2011 → Jun 2014 | asthma | Imperial College London | Completed | Missed primary |
| Comparator or background therapy2 trials | ||||||
| Phase 1 | NCT00830206 Comparator | Jan 2006 | — | Teva Pharmaceuticals USA | Completed | No outcome recorded |
| Phase 1 | NCT00865670 Comparator | Aug → Sep 2003 | infectious disease | Sandoz | Completed | No outcome recorded |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | zithromax | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02288832 ↗ |
| Known as | azithromycin dihydrate | “Zithromax (azithromycin dihydrate) 600 mg Tablets” NCT00865670 ↗ |
| Route | Oral | “Zithromax® Oral Suspension 200 mg/5 mL (reference)” NCT00830206 ↗ |