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FDA NDA · NDA008720

LEVO-DROMORAN

Sponsor: VALEANT PHARM INTL

APPLICATION
NDA008720
TYPE
NDA
ORIGINAL APPROVAL
1953-01-08
LATEST ACTION
2004-09-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

LEVO-DROMORAN · ReferenceDiscontinued
LEVORPHANOL TARTRATE 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2004-09-03Manufacturing (CMC) · Supplement 16 · priority — Letter ↗AP
1998-01-26Manufacturing (CMC) · Supplement 15 · priorityAP
1991-12-19Efficacy · Supplement 6 · priorityAP
1986-02-25Manufacturing (CMC) · Supplement 14 · priorityAP
1983-02-03Manufacturing (CMC) · Supplement 13 · priorityAP
1981-03-03Manufacturing (CMC) · Supplement 11 · priorityAP
1979-06-25Manufacturing (CMC) · Supplement 9 · priorityAP
1978-02-07Manufacturing (CMC) · Supplement 8 · priorityAP
1953-01-08Type 3 - New Dosage Form · Original · priorityAP
VIEW ON DRUGS@FDA ↗

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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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