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FDA NDA · NDA019115

FENTANYL CITRATE

Sponsor: HOSPIRA

APPLICATION
NDA019115
TYPE
NDA
ORIGINAL APPROVAL
1985-01-12
LATEST ACTION
2025-12-22
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

FENTANYL CITRATEPrescription
FENTANYL CITRATE EQ 0.05MG BASE/ML · INJECTABLE · INJECTION

Approval history

2025-12-22Labeling · Supplement 48 · standard — Letter ↗AP
2023-12-15Labeling · Supplement 42 · standard — Label ↗AP
2019-10-07Labeling · Supplement 33 · standard — Label ↗AP
2016-12-16Labeling · Supplement 31 · standard — Letter ↗AP
2016-12-16Labeling · Supplement 21 · standardAP
2016-12-16Labeling · Supplement 30 · standard — Letter ↗AP
2005-07-19Labeling · Supplement 18AP
2002-10-25Manufacturing (CMC) · Supplement 17 · standardAP
2002-10-07Manufacturing (CMC) · Supplement 16 · standardAP
1999-08-04Manufacturing (CMC) · Supplement 15 · standardAP
1996-10-03Manufacturing (CMC) · Supplement 13 · standardAP
1993-08-30Manufacturing (CMC) · Supplement 10 · standardAP
1993-07-30Manufacturing (CMC) · Supplement 11 · standardAP
1992-04-08Labeling · Supplement 9AP
1992-03-10Manufacturing (CMC) · Supplement 5 · standardAP
1991-07-18Manufacturing (CMC) · Supplement 8 · standardAP
1991-07-18Manufacturing (CMC) · Supplement 7 · standardAP
1990-07-09Labeling · Supplement 6AP
1989-05-17Labeling · Supplement 4AP
1985-01-12Type 5 - New Formulation or New Manufacturer · Original · standardAP
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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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