All regulations
Nonrulemaking
FDA
Open for Comments
FDA-2026-P-8250
Requests that the FDA declare that the proposed drug product, Levoketoconazole Tablets, 300 mg, is suitable for submission as an ANDA.
Documents
5
Comments
0
Key Dates
Comment Period OpensJul 28, 2026
Documents
| Type | Title | Status |
|---|---|---|
Supporting Material |
Keywords
CDER
Suitability Petition
Lachman Consultant Services Inc
declare that the proposed drug product
Levoketoconazole Tablets 300 mg
is suitable for submission as an ANDA
OPEN
Data from Regulations.gov