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FDA NDA · NDA012429

TABLOID

thioguanine

Sponsor: WAYLIS THERAP

APPLICATION
NDA012429
TYPE
NDA
ORIGINAL APPROVAL
1966-01-18
LATEST ACTION
2024-07-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

THIOGUANINE · ReferencePrescription
THIOGUANINE 40MG · TABLET · ORAL

Approval history

2024-07-09Labeling · Supplement 29 · standard — Letter ↗AP
2018-05-23Labeling · Supplement 28 · standard — Letter ↗AP
2004-11-15Labeling · Supplement 22 · standard — Label ↗AP
2003-12-19Labeling · Supplement 21 · standard — Label ↗AP
2003-06-30Labeling · Supplement 19 · standard — Letter ↗AP
2002-07-03Manufacturing (CMC) · Supplement 18 · priorityAP
2001-12-12Labeling · Supplement 17 · standard — Letter ↗AP
1991-07-15Labeling · Supplement 15AP
1990-04-05Manufacturing (CMC) · Supplement 14 · priorityAP
1988-07-18Manufacturing (CMC) · Supplement 11 · priorityAP
1987-04-09Labeling · Supplement 13AP
1986-09-22Labeling · Supplement 12AP
1985-11-20Labeling · Supplement 10AP
1985-08-06Manufacturing (CMC) · Supplement 9 · priorityAP
1984-03-13Labeling · Supplement 8AP
1978-08-24Labeling · Supplement 7AP
1977-02-11Manufacturing (CMC) · Supplement 6 · priorityAP
1966-01-18Type 1 - New Molecular Entity · Original · priorityAP
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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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