APPLICATION
ANDA074413
TYPE
ANDA
ORIGINAL APPROVAL
1995-12-15
LATEST ACTION
2024-01-22
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
SUFENTANIL CITRATEDiscontinued
SUFENTANIL CITRATE EQ 0.05MG BASE/ML · INJECTABLE · INJECTION
Approval history
2024-01-22Labeling · Supplement 24 · standardAP
2024-01-22Labeling · Supplement 25 · standardAP
2024-01-19Labeling · Supplement 23 · standardAP
2004-04-22Labeling · Supplement 15AP
2000-03-27Manufacturing (CMC) · Supplement 12AP
1998-05-07Labeling · Supplement 9AP
1998-04-10Manufacturing (CMC) · Supplement 11AP
1998-04-10Manufacturing (CMC) · Supplement 10AP
1997-05-02Manufacturing (CMC) · Supplement 6AP
1997-05-02Manufacturing (CMC) · Supplement 4AP
1997-05-02Labeling · Supplement 7AP
1997-05-02Manufacturing (CMC) · Supplement 5AP
1997-01-31Labeling · Supplement 8AP
1996-09-06Labeling · Supplement 3AP
1996-07-17Manufacturing (CMC) · Supplement 1AP
1996-05-01Labeling · Supplement 2AP
1995-12-15OriginalAP
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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