APPLICATION
ANDA075221
TYPE
ANDA
ORIGINAL APPROVAL
1999-10-28
LATEST ACTION
2024-03-28
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
ALFENTANILDiscontinued
ALFENTANIL HYDROCHLORIDE EQ 0.5MG BASE/ML · INJECTABLE · INJECTION
Approval history
2024-03-28Labeling · Supplement 22 · standardAP
2024-01-26Labeling · Supplement 20 · standardAP
2021-07-16Labeling · Supplement 16 · standardAP
2021-07-16Labeling · Supplement 12 · standardAP
2002-12-20Manufacturing (CMC) · Supplement 2AP
1999-11-24Labeling · Supplement 1AP
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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