FDA · United States
citric acid — FDA regulatory status
citric acid (UROLOGIC G IN PLASTIC CONTAINER) 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
- UROLOGIC G IN PLASTIC CONTAINER
- Originator
- United Therapeutics Europe Ltd
- Structured fields
- 6
Sponsor / originator context: United Therapeutics Europe Ltd. Pipeline programs and exclusivity signals below are joined from ClinicalTrials.gov-linked projects and USPTO/EPO patent rows associated with this INN.
Regional decision snapshot — FDA: approved.
Linked evidence on this spoke: 2 published clinical programs and 12 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 |
|---|---|---|---|
| AERD-COV19 | Phase 3 | COLLEGIUM PHARMACEUTICAL | 2024-514602-31-00 |
| UIC-BKL-2013 | Phase 3 | Universal Integrated | NCT01984008 |
Related patents
| Number | Title | Jurisdiction |
|---|---|---|
| 12415845 | Methods of producing T cell populations using hydroxycitric acid and/or a salt thereof | US |
| 12383500 | Nanoliposome compositions and methods of using the same | US |
| 12383618 | Expression vector delivery system and use thereof for inducing an immune response | US |
| 12384820 | Griffithsin mutants | US |
| 12383554 | Compositions and methods to protect mammalian tissue against cold and other metabolic stresses | US |
| 12350274 | Nucleotide analogs | US |
| 12343432 | Encapsulated probiotic | US |
| 12336974 | Methods and compositions for preventing and treating auditory dysfunctions | US |
| 12325688 | Gingerenone A prodrugs as sensotherapeutics and methods of use | US |
| 12298315 | Systems and methods to identify and treat subjects at risk for obstetrical complications | US |
| 12286657 | Methods and compositions | US |
| 12281060 | Remodilins for airway remodeling and organ fibrosis | US |
Related hubs
FAQ
What is the FDA approval status of citric acid?
citric acid 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 citric acid 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 citric acid?
This spoke lists 2 published programs associated with citric acid in our pipeline index.