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FDA NDA · NDA009386

MYLERAN

busulfan

Sponsor: WAYLIS THERAP

APPLICATION
NDA009386
TYPE
NDA
ORIGINAL APPROVAL
1954-06-26
LATEST ACTION
2003-12-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

MYLERAN · ReferencePrescription
BUSULFAN 2MG · TABLET · ORAL

Approval history

2003-12-24Labeling · Supplement 23 · standard — Letter ↗AP
2003-04-16Labeling · Supplement 21 · standard — Letter ↗AP
2003-01-23Manufacturing (CMC) · Supplement 19 · priority — Review ↗AP
2002-09-20Labeling · Supplement 20 · standardAP
2000-09-06Labeling · Supplement 18 · standardAP
2000-03-15Labeling · Supplement 17 · standardAP
1997-12-23Manufacturing (CMC) · Supplement 16 · priorityAP
1994-07-29Labeling · Supplement 15 · standardAP
1991-07-15Labeling · Supplement 13 — Label ↗AP
1990-09-17Labeling · Supplement 12AP
1990-03-20Manufacturing (CMC) · Supplement 11 · priorityAP
1987-04-09Labeling · Supplement 9AP
1987-04-09Labeling · Supplement 10AP
1986-05-19Labeling · Supplement 8AP
1981-05-11Labeling · Supplement 7AP
1979-11-08Labeling · Supplement 6AP
1977-02-10Manufacturing (CMC) · Supplement 5 · priorityAP
1975-11-21REMS · Supplement 4 · priorityAP
1954-06-26Type 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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