← FDA DRUG APPROVALS

FDA NDA · NDA010669

LEUKERAN

chlorambucil

Sponsor: WAYLIS THERAP

APPLICATION
NDA010669
TYPE
NDA
ORIGINAL APPROVAL
1957-03-18
LATEST ACTION
2011-10-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

LEUKERAN · ReferencePrescription
CHLORAMBUCIL 2MG · TABLET · ORAL

Approval history

2011-10-28Labeling · Supplement 32 · unknown — Letter ↗AP
2010-04-23Labeling · Supplement 30 · standard — Letter ↗AP
2005-05-24Labeling · Supplement 29 · standard — Letter ↗AP
2003-11-13Labeling · Supplement 28 · standard — Label ↗AP
2002-11-14Manufacturing (CMC) · Supplement 25 · priorityAP
2001-07-24Manufacturing (CMC) · Supplement 23 · priority — Letter ↗AP
2001-07-24Manufacturing (CMC) · Supplement 21 · priority — Letter ↗AP
2001-07-24Manufacturing (CMC) · Supplement 22 · priority — Letter ↗AP
2001-06-20Labeling · Supplement 24 · standard — Letter ↗AP
1996-02-09Labeling · Supplement 17 · standardAP
1995-06-29Manufacturing (CMC) · Supplement 20 · priorityAP
1994-02-04Manufacturing (CMC) · Supplement 18 · priorityAP
1992-10-14Manufacturing (CMC) · Supplement 16 · priorityAP
1990-03-06Manufacturing (CMC) · Supplement 14 · priorityAP
1989-02-28Labeling · Supplement 15AP
1986-09-22Labeling · Supplement 12AP
1984-03-12Labeling · Supplement 11AP
1981-08-27Labeling · Supplement 9AP
1979-02-15Manufacturing (CMC) · Supplement 6 · priorityAP
1978-06-08Manufacturing (CMC) · Supplement 8 · priorityAP
1978-03-22Manufacturing (CMC) · Supplement 7 · priorityAP
1977-03-09Manufacturing (CMC) · Supplement 5 · priorityAP
1957-03-18Type 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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