APPLICATION
ANDA074534
TYPE
ANDA
ORIGINAL APPROVAL
1996-12-11
LATEST ACTION
2026-06-25
ROUTE
EPIDURAL, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
SUFENTANIL CITRATEPrescription
SUFENTANIL CITRATE EQ 0.05MG BASE/ML · INJECTABLE · INJECTION
Approval history
2026-06-25Labeling · Supplement 22 · standardAP
2024-08-22Labeling · Supplement 20 · standardAP
2024-01-26Labeling · Supplement 19 · standardAP
2021-06-25Labeling · Supplement 14 · standardAP
2021-06-25Labeling · Supplement 15 · standardAP
2016-01-26Labeling · Supplement 12 · standardAP
2002-10-25Manufacturing (CMC) · Supplement 4AP
2002-06-06Manufacturing (CMC) · Supplement 3AP
1998-03-13Labeling · Supplement 1AP
1996-12-11OriginalAP
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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