FDA · United States
primaquine phosphate — FDA regulatory status
primaquine phosphate (PRIMAQUINE PHOSPHATE) regulatory status in the United States is tracked from public FDA records and cross-linked clinical and patent datasets on NovaPharmaNews. Current status: FDA approved.
Status snapshot
- Status
- FDA approved
- Brand
- PRIMAQUINE PHOSPHATE
- Mechanism
- Unknown
- Structured fields
- 5
Pharmacology context used for competitive intelligence: Unknown. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — FDA: approved.
Linked evidence on this spoke: 3 published clinical programs and 0 related patent records. Use the tables below for NCT identifiers, phases, and exclusivity dates; verify against primary sources before BD or medical decisions.
Regulatory timeline
| Regulator | Region | Status | Date | Source |
|---|---|---|---|---|
| FDA | United States | approved | — | Evidence |
Linked clinical programs
| Program | Phase | Sponsor | NCT |
|---|---|---|---|
| ITDCVC98 | Phase 3 | United Therapeutics Europe | NCT00158548 |
Related hubs
FAQ
What is the FDA approval status of primaquine phosphate?
primaquine phosphate currently shows FDA approved in our United States regulatory index. Confirm on the official FDA label or EPAR before clinical or commercial use.
Where does NovaPharmaNews get primaquine phosphate regulatory data?
Status fields are joined from public sources (openFDA / EMA / regional agencies), ClinicalTrials.gov-linked programs, and patent registries. See /about/data-sources for attribution.
How many clinical programs are linked to primaquine phosphate?
This spoke lists 3 published programs associated with primaquine phosphate in our pipeline index.