← FDA DRUG APPROVALS

FDA ANDA · ANDA079075

FENTANYL CITRATE

Sponsor: WATSON LABS

APPLICATION
ANDA079075
TYPE
ANDA
ORIGINAL APPROVAL
2011-01-07
LATEST ACTION
2024-08-28
ROUTE
BUCCAL, SUBLINGUAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

FENTANYL CITRATEDiscontinued
FENTANYL CITRATE EQ 0.6MG BASE · TABLET · BUCCAL, SUBLINGUAL
FENTANYL CITRATEDiscontinued
FENTANYL CITRATE EQ 0.2MG BASE · TABLET · BUCCAL, SUBLINGUAL
FENTANYL CITRATEDiscontinued
FENTANYL CITRATE EQ 0.8MG BASE · TABLET · BUCCAL, SUBLINGUAL
FENTANYL CITRATEDiscontinued
FENTANYL CITRATE EQ 0.4MG BASE · TABLET · BUCCAL, SUBLINGUAL
FENTANYL CITRATEDiscontinued
FENTANYL CITRATE EQ 0.1MG BASE · TABLET · BUCCAL, SUBLINGUAL

Approval history

2024-08-28REMS · Supplement 18AP
2022-12-08REMS · Supplement 17AP
2022-08-17REMS · Supplement 16AP
2021-12-03REMS · Supplement 15AP
2020-12-23REMS · Supplement 14AP
2017-09-07REMS · Supplement 13AP
2017-04-12Labeling · Supplement 12 · standardAP
2016-01-08Labeling · Supplement 11 · standardAP
2016-01-08REMS · Supplement 10AP
2015-05-03Labeling · Supplement 2AP
2015-05-03Labeling · Supplement 9 · standardAP
2011-01-07Original — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →