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FDA NDA · NDA009053

MERCAPTOPURINE

Sponsor: STASON PHARMS

APPLICATION
NDA009053
TYPE
NDA
ORIGINAL APPROVAL
1953-09-11
LATEST ACTION
2024-07-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

PURINETHOL · ReferencePrescription
MERCAPTOPURINE 50MG · TABLET · ORAL

Approval history

2024-07-09Labeling · Supplement 44 · standard — Letter ↗AP
2020-12-29Labeling · Supplement 40 · standard — Letter ↗AP
2020-04-29Labeling · Supplement 39 · standard — Letter ↗AP
2018-05-23Labeling · Supplement 35 · standard — Label ↗AP
2011-05-27Labeling · Supplement 32 · 901 required — Label ↗AP
2004-07-15Labeling · Supplement 24 · standard — Label ↗AP
2003-01-10Labeling · Supplement 22 · standard — Letter ↗AP
2002-09-06Labeling · Supplement 21 · standard — Letter ↗AP
2002-03-22Labeling · Supplement 20 · standard — Letter ↗AP
2001-05-16Manufacturing (CMC) · Supplement 16 · priorityAP
2001-04-03Manufacturing (CMC) · Supplement 19 · priorityAP
1996-04-15Labeling · Supplement 18 · standardAP
1987-11-17Manufacturing (CMC) · Supplement 15 · priorityAP
1987-05-20Labeling · Supplement 14AP
1987-04-09Labeling · Supplement 13AP
1986-10-14Labeling · Supplement 9AP
1986-09-23Labeling · Supplement 12AP
1985-11-20Manufacturing (CMC) · Supplement 10 · priorityAP
1982-10-19Manufacturing (CMC) · Supplement 8 · priorityAP
1979-12-19Labeling · Supplement 7AP
1977-02-15Manufacturing (CMC) · Supplement 6 · priorityAP
1953-09-11Type 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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