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FDA NDA · NDA214133

RECORLEV

levoketoconazole

Sponsor: STRONGBRIDGE

APPLICATION
NDA214133
TYPE
NDA
ORIGINAL APPROVAL
2021-12-30
LATEST ACTION
2023-08-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

RECORLEV · ReferencePrescription
LEVOKETOCONAZOLE 150MG · TABLET · ORAL

Approval history

2023-08-16Labeling · Supplement 3 · standard — Letter ↗AP
2021-12-30Type 2 - New Active Ingredient · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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