← FDA DRUG APPROVALS

FDA NDA · NDA019101

FENTANYL CITRATE

Sponsor: HIKMA

APPLICATION
NDA019101
TYPE
NDA
ORIGINAL APPROVAL
1984-07-11
LATEST ACTION
2025-12-22
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

FENTANYL CITRATE · ReferencePrescription
FENTANYL CITRATE EQ 0.025MG BASE/0.5ML · INJECTABLE · INJECTION
FENTANYL CITRATE · ReferencePrescription
FENTANYL CITRATE EQ 0.05MG BASE/ML · INJECTABLE · INJECTION

Approval history

2025-12-22Labeling · Supplement 74 · standard — Letter ↗AP
2025-09-25Labeling · Supplement 72 · standard — Label ↗AP
2023-12-15Labeling · Supplement 65 · standard — Label ↗AP
2023-12-15Labeling · Supplement 63 · standard — Label ↗AP
2023-03-03Manufacturing (CMC) · Supplement 61 · standardAP
2023-01-20Manufacturing (CMC) · Supplement 60 — Label ↗AP
2019-10-08Labeling · Supplement 51 · standard — Letter ↗AP
2019-01-24Labeling · Supplement 47 · standard — Label ↗AP
2016-12-16Labeling · Supplement 45 · standard — Letter ↗AP
2016-05-26Manufacturing (CMC) · Supplement 44AP
2016-02-12Manufacturing (CMC) · Supplement 43AP
2015-11-09Manufacturing (CMC) · Supplement 42AP
2015-01-20Manufacturing (CMC) · Supplement 41AP
2014-05-21Manufacturing (CMC) · Supplement 40AP
2014-03-20Manufacturing (CMC) · Supplement 39AP
2013-02-06Labeling · Supplement 37AP
2012-02-13Labeling · Supplement 33AP
2010-02-25Labeling · Supplement 31AP
2001-08-28Manufacturing (CMC) · Supplement 20AP
2001-06-29Manufacturing (CMC) · Supplement 19AP
1999-05-20Manufacturing (CMC) · Supplement 18AP
1998-11-02Manufacturing (CMC) · Supplement 17AP
1996-08-15Manufacturing (CMC) · Supplement 16AP
1994-03-25Labeling · Supplement 15AP
1992-06-25Manufacturing (CMC) · Supplement 11AP
1991-08-07Manufacturing (CMC) · Supplement 12AP
1991-08-07Labeling · Supplement 13AP
1991-05-01Labeling · Supplement 14AP
1990-01-11Labeling · Supplement 10AP
1989-11-16Labeling · Supplement 9AP
1986-11-19Manufacturing (CMC) · Supplement 6AP
1985-11-05Manufacturing (CMC) · Supplement 1AP
1985-11-05Manufacturing (CMC) · Supplement 2AP
1985-01-30Manufacturing (CMC) · Supplement 4AP
1984-07-11OriginalAP
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 →