← FDA DRUG APPROVALS

FDA NDA · NDA019926

HEXALEN

Sponsor: EISAI INC

APPLICATION
NDA019926
TYPE
NDA
ORIGINAL APPROVAL
1990-12-26
LATEST ACTION
2014-08-29
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

HEXALEN · ReferenceDiscontinued
ALTRETAMINE 50MG · CAPSULE · ORAL

Approval history

2014-08-29Manufacturing (CMC) · Supplement 25 · priorityAP
2014-01-09Manufacturing (CMC) · Supplement 24 · priorityAP
2013-02-28Manufacturing (CMC) · Supplement 23 · priorityAP
2001-07-11Manufacturing (CMC) · Supplement 17 · priorityAP
1999-10-19Manufacturing (CMC) · Supplement 16 · priorityAP
1997-04-11Manufacturing (CMC) · Supplement 15 · priorityAP
1995-07-11Manufacturing (CMC) · Supplement 14 · priorityAP
1995-06-23Manufacturing (CMC) · Supplement 13 · priorityAP
1994-07-26Manufacturing (CMC) · Supplement 12 · priorityAP
1993-03-12Manufacturing (CMC) · Supplement 11 · priorityAP
1993-02-10Labeling · Supplement 10AP
1993-01-14Manufacturing (CMC) · Supplement 5 · priorityAP
1993-01-14Manufacturing (CMC) · Supplement 3 · priorityAP
1992-05-29Manufacturing (CMC) · Supplement 9 · priorityAP
1992-03-19Manufacturing (CMC) · Supplement 8 · priorityAP
1991-10-22Manufacturing (CMC) · Supplement 7 · priorityAP
1991-09-20Manufacturing (CMC) · Supplement 6 · priorityAP
1991-04-26Manufacturing (CMC) · Supplement 4 · priorityAP
1991-03-14Manufacturing (CMC) · Supplement 1 · priorityAP
1990-12-26Type 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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