Nonrulemaking

Requests that the FDA declare that the proposed drug product, Levoketoconazole Tablets, 300 mg, is suitable for submission as an ANDA.

🏛 Food and Drug Administration (FDA)FDA-2026-P-8250

Pharmaceutical Policy

Documents

5

Total comments

0

all analyzed

Comment status

Open

Last activity

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In this docket

Documents

Rules, notices, and supporting material — the primary rule pinned first.

All 5 Supporting & Related Material 3 Other 2

📄 Primary document

OtherJul 28, 2026

Suitability Petition from Lachman Consultant Services, Inc.

No comment period

Other· Jul 28, 2026
Acknowledgement Letter from FDA DMB to Lachman Consultant Services, Inc.→
No comment period
Supporting & Related Material· Jul 28, 2026
Attachment 1 - Orange Book Approved Drug Products with Therapeutic Equivalence Evaluations→
Supporting & Related Material· Jul 28, 2026
Attachment 2 - Current Package Insert for RECORLEV, NDA#214133→
Supporting & Related Material· Jul 28, 2026
Attachment 3 - Draft Package Insert Proposed for Levoketoconazole Tablets, 300 mg→