APPLICATION
ANDA077312
TYPE
ANDA
ORIGINAL APPROVAL
2009-10-30
LATEST ACTION
2017-09-07
ROUTE
TRANSMUCOSAL
DOSAGE FORM
TROCHE/LOZENGE
MARKETING STATUS
Discontinued
Products
FENTANYL CITRATEDiscontinued
FENTANYL CITRATE EQ 0.6MG BASE · TROCHE/LOZENGE · TRANSMUCOSAL
FENTANYL CITRATEDiscontinued
FENTANYL CITRATE EQ 0.2MG BASE · TROCHE/LOZENGE · TRANSMUCOSAL
FENTANYL CITRATEDiscontinued
FENTANYL CITRATE EQ 1.6MG BASE · TROCHE/LOZENGE · TRANSMUCOSAL
FENTANYL CITRATEDiscontinued
FENTANYL CITRATE EQ 0.8MG BASE · TROCHE/LOZENGE · TRANSMUCOSAL
FENTANYL CITRATEDiscontinued
FENTANYL CITRATE EQ 0.4MG BASE · TROCHE/LOZENGE · TRANSMUCOSAL
FENTANYL CITRATEDiscontinued
FENTANYL CITRATE EQ 1.2MG BASE · TROCHE/LOZENGE · TRANSMUCOSAL
Approval history
2017-09-07REMS · Supplement 9AP
2017-04-14Labeling · Supplement 8 · standardAP
2014-12-24REMS · Supplement 6AP
2013-11-07REMS · Supplement 5AP
2012-06-29Labeling · Supplement 4 · standardAP
2012-06-08Labeling · Supplement 3AP
2012-01-20Labeling · Supplement 1AP
2011-12-28Labeling · Supplement 2AP
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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