APPLICATION
ANDA072786
TYPE
ANDA
ORIGINAL APPROVAL
1991-09-24
LATEST ACTION
2024-07-15
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
FENTANYL CITRATE PRESERVATIVE FREEDiscontinued
FENTANYL CITRATE EQ 0.05MG BASE/ML · INJECTABLE · INJECTION
Approval history
2024-07-15Labeling · Supplement 45 · standardAP
2024-01-22Labeling · Supplement 42 · standardAP
2024-01-19Labeling · Supplement 40 · standardAP
2020-06-11Labeling · Supplement 26 · standardAP
2020-06-11Labeling · Supplement 16 · standardAP
2020-06-11Labeling · Supplement 14 · standardAP
2001-02-14Manufacturing (CMC) · Supplement 4AP
1995-12-22Manufacturing (CMC) · Supplement 3AP
1994-03-16Manufacturing (CMC) · Supplement 2AP
1991-09-24OriginalAP
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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