← FDA DRUG APPROVALS

FDA NDA · NDA019353

ALFENTA

Sponsor: RISING

APPLICATION
NDA019353
TYPE
NDA
ORIGINAL APPROVAL
1986-12-29
LATEST ACTION
2025-12-22
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

ALFENTA · ReferencePrescription
ALFENTANIL HYDROCHLORIDE EQ 0.5MG BASE/ML · INJECTABLE · INJECTION

Approval history

2025-12-22Labeling · Supplement 31 · standard — Letter ↗AP
2023-12-15Labeling · Supplement 29 · standard — Label ↗AP
2022-08-08Manufacturing (CMC) · Supplement 24 — Letter ↗TA
2019-10-07Labeling · Supplement 23 · standard — Label ↗AP
2016-12-16Labeling · Supplement 21 · standard — Letter ↗AP
2015-07-24Labeling · Supplement 19 · standard — Label ↗AP
1999-05-25Manufacturing (CMC) · Supplement 16 · standardAP
1998-01-20Manufacturing (CMC) · Supplement 15 · standardAP
1997-01-28Manufacturing (CMC) · Supplement 14 · standardAP
1995-10-30Labeling · Supplement 13 · standardAP
1995-08-03Manufacturing (CMC) · Supplement 10 · standardAP
1995-02-22Manufacturing (CMC) · Supplement 11 · standardAP
1994-08-18Manufacturing (CMC) · Supplement 9 · standardAP
1994-01-07Manufacturing (CMC) · Supplement 5 · standardAP
1994-01-07Manufacturing (CMC) · Supplement 6 · standardAP
1993-11-22Efficacy · Supplement 8 · standardAP
1992-11-10Manufacturing (CMC) · Supplement 7 · standardAP
1991-08-07Manufacturing (CMC) · Supplement 4 · standardAP
1990-12-06Manufacturing (CMC) · Supplement 3 · standardAP
1990-07-05Manufacturing (CMC) · Supplement 2 · standardAP
1988-07-28Labeling · Supplement 1AP
1986-12-29Type 1 - New Molecular Entity · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

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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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