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FDA NDA · NDA019569

THIOLA

tiopronin

Sponsor: MISSION PHARMA

APPLICATION
NDA019569
TYPE
NDA
ORIGINAL APPROVAL
1988-08-11
LATEST ACTION
2019-06-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

THIOLA · ReferencePrescription
TIOPRONIN 100MG · TABLET · ORAL

Approval history

2019-06-28Labeling · Supplement 6 · standard — Letter ↗AP
2001-10-01Manufacturing (CMC) · Supplement 1 · priorityAP
2000-12-15Manufacturing (CMC) · Supplement 2 · priorityAP
1988-08-11Type 1 - New Molecular Entity · Original · priorityAP
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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