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FDA NDA · NDA205919

MERCAPTOPURINE

Sponsor: NOVA LABS LTD

APPLICATION
NDA205919
TYPE
NDA
ORIGINAL APPROVAL
2014-04-28
LATEST ACTION
2026-07-16
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Prescription

Products

PURIXAN · ReferencePrescription
MERCAPTOPURINE 20MG/ML · SUSPENSION · ORAL

Approval history

2026-07-16Labeling · Supplement 9 · standard — Letter ↗AP
2024-10-23Labeling · Supplement 7 · standard — Letter ↗AP
2024-07-09Labeling · Supplement 8 · standard — Letter ↗AP
2020-04-07Labeling · Supplement 4 · standard — Letter ↗AP
2018-02-20Labeling · Supplement 3 · standard — Label ↗AP
2017-05-08Labeling · Supplement 2 · standard — Label ↗AP
2014-12-23Manufacturing (CMC) · Supplement 1 · standard — Letter ↗AP
2014-04-28Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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