Penicillin v
As of the edition of 20 October 2026, Penicillin v is a small molecule: marketed, first approved in 1969 (ES).
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1985
- Kind
- Small molecule
- Brand name
- Penilevel
- First approved
- 1 March 1969 (ES)
- Approvals on record
- 4 in 4 regions
- Holder of the most recent approval
- AA PHARMA INC; 4 holders in all
- Registered trials
- 7, 1 stopped early
- Disease areas
- Infections; Lungs and airways; Blood and lymph; Ear, nose and throat; Heart and blood vessels; Mouth and teeth
US protection
No US approval on record.
With no US approval on record there are no listed US patents or exclusivities.
This is the US only.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 1 | 2 | 2 | 0 | 0 |
| Phase 2 | 1 | 0 | 1 | 0 |
| Phase 3 | 1 | 0 | 0 | 1 |
| Phase 4 | 3 | 3 | 0 | 0 |
| All trials | 7 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Eurofarma Laboratorios | Applicant | 1978 to now |