APPLICATION
ANDA216990
TYPE
ANDA
ORIGINAL APPROVAL
2024-01-30
LATEST ACTION
2024-07-26
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Prescription
Products
VENXXIVAPrescription
TIOPRONIN 100MG · TABLET, DELAYED RELEASE · ORAL
VENXXIVAPrescription
TIOPRONIN 300MG · TABLET, DELAYED RELEASE · ORAL
Approval history
2024-07-26Labeling · Supplement 1 · 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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