Drugs / Novolin R
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | NOVOLIN R | — | 2005-10-21 | fda.gov ↗ |
| Approved | US (FDA) | NOVOLIN R | — | 1991-06-25 | fda.gov ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase not applicable1 trial | ||||||
| — | NCT00282594 | Jul 2003 → Oct 2005 | infectious disease with sepsis, kidney failure, respiratory failure | Genesys | Completed | No outcome recorded |
| Comparator or background therapy3 trials | ||||||
| Phase 1 | NCT04975022 Comparator | Dec 2019 → Aug 2020 | — | Beijing Hospital | Completed | No outcome recorded |
| Phase 1 | NCT00596063 Comparator | Jan → Feb 2008 | diabetes mellitus | Wockhardt | Completed | No outcome recorded |
| — | NCT01833559 Background | Jun 2012 → May 2021 | gestational diabetes | First Affiliated Hospital, Sun Yat-Sen University | Unknown | No outcome recorded |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Novolin R | “Novolin R” NCT01833559 ↗ |
| Known as | human recombinant Insulin | “Novolin R (human recombinant Insulin)” NCT00282594 ↗ |
| Modality | Protein / enzyme biologic | “human recombinant Insulin” NCT00282594 ↗ |
| Route | Subcutaneous | “administered subcutaneously” NCT00596063 ↗ |