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FDA NDA · NDA019050

SUFENTA PRESERVATIVE FREE

Sponsor: RISING

APPLICATION
NDA019050
TYPE
NDA
ORIGINAL APPROVAL
1984-05-04
LATEST ACTION
2025-12-22
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

SUFENTA PRESERVATIVE FREE · ReferencePrescription
SUFENTANIL CITRATE EQ 0.05MG BASE/ML · INJECTABLE · INJECTION

Approval history

2025-12-22Labeling · Supplement 45 · standard — Letter ↗AP
2023-12-15Labeling · Supplement 43 · standard — Letter ↗AP
2019-10-07Labeling · Supplement 37 · standard — Label ↗AP
2016-12-16Labeling · Supplement 34 · standard — Letter ↗AP
2014-03-20Labeling · Supplement 32 · standard — Letter ↗AP
2007-06-04Labeling · Supplement 31 · standard — Label ↗AP
2001-08-27Labeling · Supplement 25 · standardAP
1999-05-25Manufacturing (CMC) · Supplement 28 · priorityAP
1998-05-26Manufacturing (CMC) · Supplement 27 · priorityAP
1998-05-01Manufacturing (CMC) · Supplement 26 · priorityAP
1997-08-12Manufacturing (CMC) · Supplement 23 · priorityAP
1996-06-21Labeling · Supplement 24 · standardAP
1995-02-22Manufacturing (CMC) · Supplement 22 · priorityAP
1994-03-23Manufacturing (CMC) · Supplement 19 · priorityAP
1994-03-23Manufacturing (CMC) · Supplement 18 · priorityAP
1994-03-23Manufacturing (CMC) · Supplement 20 · priorityAP
1993-03-19Efficacy · Supplement 17AP
1992-11-10Manufacturing (CMC) · Supplement 21 · priorityAP
1990-10-05Manufacturing (CMC) · Supplement 14 · priorityAP
1987-04-29Manufacturing (CMC) · Supplement 11 · priorityAP
1986-11-14Manufacturing (CMC) · Supplement 9 · priorityAP
1986-11-14Labeling · Supplement 10AP
1986-08-06Manufacturing (CMC) · Supplement 8 · priorityAP
1986-06-20Manufacturing (CMC) · Supplement 4 · priorityAP
1986-03-18Labeling · Supplement 6AP
1986-03-18Manufacturing (CMC) · Supplement 7 · priorityAP
1985-08-21Manufacturing (CMC) · Supplement 2 · priorityAP
1985-08-21Labeling · Supplement 3AP
1984-09-10Manufacturing (CMC) · Supplement 1 · priorityAP
1984-05-04Type 1 - New Molecular Entity · Original · priorityAP
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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