APPLICATION
ANDA207338
TYPE
ANDA
ORIGINAL APPROVAL
2017-11-17
LATEST ACTION
2024-08-28
ROUTE
SUBLINGUAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
FENTANYL CITRATEDiscontinued
FENTANYL CITRATE EQ 0.8MG BASE · TABLET · SUBLINGUAL
FENTANYL CITRATEDiscontinued
FENTANYL CITRATE EQ 0.4MG BASE · TABLET · SUBLINGUAL
FENTANYL CITRATEDiscontinued
FENTANYL CITRATE EQ 0.2MG BASE · TABLET · SUBLINGUAL
FENTANYL CITRATEDiscontinued
FENTANYL CITRATE EQ 0.6MG BASE · TABLET · SUBLINGUAL
FENTANYL CITRATEDiscontinued
FENTANYL CITRATE EQ 0.3MG BASE · TABLET · SUBLINGUAL
FENTANYL CITRATEDiscontinued
FENTANYL CITRATE EQ 0.1MG BASE · TABLET · SUBLINGUAL
Approval history
2024-08-28REMS · Supplement 10AP
2023-12-15Labeling · Supplement 8 · standardAP
2023-12-15Labeling · Supplement 6 · standardAP
2023-12-15Labeling · Supplement 7 · standardAP
2023-12-14Labeling · Supplement 5 · standardAP
2022-12-08REMS · Supplement 4AP
2022-08-17REMS · Supplement 3AP
2021-12-03REMS · Supplement 2AP
2020-12-23REMS · Supplement 1AP
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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