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FDA NDA · NDA210867

MOXIDECTIN

Sponsor: MDGH

APPLICATION
NDA210867
TYPE
NDA
ORIGINAL APPROVAL
2018-06-13
LATEST ACTION
2025-02-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

MOXIDECTIN · ReferencePrescription
MOXIDECTIN 2MG · TABLET · ORAL

Approval history

2025-02-07Efficacy · Supplement 6 · priority — Letter ↗AP
2021-03-05Labeling · Supplement 3 · standard — Letter ↗AP
2019-01-18Labeling · Supplement 1 · standard — Label ↗AP
2018-06-13Type 1 - New Molecular Entity · Original · priority — Label ↗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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