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FDA NDA · NDA020195

FENTANYL

Sponsor: CEPHALON

APPLICATION
NDA020195
TYPE
NDA
ORIGINAL APPROVAL
1993-10-04
LATEST ACTION
2000-09-01
ROUTE
ORAL
DOSAGE FORM
TROCHE/LOZENGE
MARKETING STATUS
Discontinued

Products

FENTANYLDiscontinued
FENTANYL CITRATE EQ 0.3MG BASE · TROCHE/LOZENGE · ORAL
FENTANYLDiscontinued
FENTANYL CITRATE EQ 0.1MG BASE · TROCHE/LOZENGE · ORAL
FENTANYLDiscontinued
FENTANYL CITRATE EQ 0.4MG BASE · TROCHE/LOZENGE · ORAL
FENTANYLDiscontinued
FENTANYL CITRATE EQ 0.2MG BASE · TROCHE/LOZENGE · ORAL

Approval history

2000-09-01Manufacturing (CMC) · Supplement 5 · priorityAP
2000-08-25Manufacturing (CMC) · Supplement 4 · priorityAP
1996-05-20Efficacy · Supplement 2 · standard — Review ↗AP
1995-10-30Efficacy · Supplement 1 · standardAP
1993-10-04Type 3 - New Dosage Form · Original · priorityAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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