FDA · United States
protein hydrolysate — FDA regulatory status
protein hydrolysate (AMINOSOL 5%) 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
- AMINOSOL 5%
- Structured fields
- 4
Regional decision snapshot — FDA: approved.
Linked evidence on this spoke: 4 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 |
|---|---|---|---|
| PRO 2000/5 | Phase 3 | United Therapeutics Europe | NCT00262106 |
| Protein C Concentrate (Human) Vapor Heated | Phase 3 | Takeda | NCT00157118 |
| Pulmonary Rehabilitation (PR) | Phase 2 | United Therapeutics Europe | NCT07104630 |
| Amino acid based formula | Unknown | United Therapeutics Europe | NCT01940068 |
Related hubs
FAQ
What is the FDA approval status of protein hydrolysate?
protein hydrolysate 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 protein hydrolysate 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 protein hydrolysate?
This spoke lists 4 published programs associated with protein hydrolysate in our pipeline index.