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FDA NDA · NDA008708

DIBENZYLINE

Sponsor: ADVANZ PHARMA

APPLICATION
NDA008708
TYPE
NDA
ORIGINAL APPROVAL
1953-01-26
LATEST ACTION
2008-04-03
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

DIBENZYLINE · ReferenceDiscontinued
PHENOXYBENZAMINE HYDROCHLORIDE 10MG · CAPSULE · ORAL

Approval history

2008-04-03Labeling · Supplement 25 · standard — Letter ↗AP
2003-12-30Labeling · Supplement 23 · standard — Letter ↗AP
2003-01-15Labeling · Supplement 22 · standard — Letter ↗AP
2001-03-30Manufacturing (CMC) · Supplement 21 · priorityAP
1995-02-03Manufacturing (CMC) · Supplement 20 · priorityAP
1991-07-12Manufacturing (CMC) · Supplement 19 · priorityAP
1991-03-01Manufacturing (CMC) · Supplement 18 · priorityAP
1988-07-28Manufacturing (CMC) · Supplement 17 · priorityAP
1987-05-27Labeling · Supplement 15AP
1984-05-25Labeling · Supplement 16AP
1983-03-15Labeling · Supplement 12AP
1953-01-26Type 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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