APPLICATION
NDA022510
TYPE
NDA
ORIGINAL APPROVAL
2011-01-07
LATEST ACTION
2019-10-07
ROUTE
SUBLINGUAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ABSTRAL · ReferenceDiscontinued
FENTANYL CITRATE EQ 0.8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · SUBLINGUAL
ABSTRAL · ReferenceDiscontinued
FENTANYL CITRATE EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · SUBLINGUAL
ABSTRAL · ReferenceDiscontinued
FENTANYL CITRATE EQ 0.2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · SUBLINGUAL
ABSTRAL · ReferenceDiscontinued
FENTANYL CITRATE EQ 0.6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · SUBLINGUAL
ABSTRAL · ReferenceDiscontinued
FENTANYL CITRATE EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · SUBLINGUAL
ABSTRAL · ReferenceDiscontinued
FENTANYL CITRATE EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · SUBLINGUAL
Approval history
2013-10-02Manufacturing (CMC) · Supplement 11 · standardAP
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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