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FDA NDA · NDA215870

FENTANYL CITRATE

Sponsor: EXELA PHARMA

APPLICATION
NDA215870
TYPE
NDA
ORIGINAL APPROVAL
2023-02-08
LATEST ACTION
2025-12-22
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

FENTANYL CITRATE · ReferenceDiscontinued
FENTANYL CITRATE EQ 2.5MG BASE/50ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · INTRAVENOUS
FENTANYL CITRATE · ReferenceDiscontinued
FENTANYL CITRATE EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · INTRAVENOUS

Approval history

2025-12-22Labeling · Supplement 2 · standard — Letter ↗AP
2023-12-15Labeling · Supplement 1 · standard — Label ↗AP
2023-02-08Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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