APPLICATION
ANDA209876
TYPE
ANDA
ORIGINAL APPROVAL
2019-09-06
LATEST ACTION
2020-12-04
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
COLCHICINEPrescription
COLCHICINE 0.6MG · TABLET · ORAL
Approval history
2020-12-04Labeling · Supplement 3 · standardAP
2020-03-30Manufacturing (CMC) · Supplement 1 · unknownAP
2019-09-06UNKNOWN · Original · standardAP
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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