← FDA DRUG APPROVALS

FDA NDA · NDA215727

LODOCO

colchicine tablets 0.5 mg

Sponsor: AGEPHA PHARMA FZ

APPLICATION
NDA215727
TYPE
NDA
ORIGINAL APPROVAL
2023-06-16
LATEST ACTION
2023-06-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

LODOCO · ReferencePrescription
COLCHICINE 0.5MG · TABLET · ORAL

Approval history

2023-06-16Type 5 - New Formulation or New Manufacturer · Original · priorityLetterAP
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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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