APPLICATION
ANDA060517
TYPE
ANDA
ORIGINAL APPROVAL
1966-03-01
LATEST ACTION
2002-11-07
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
FUNGIZONEDiscontinued
AMPHOTERICIN B 50MG/VIAL · INJECTABLE · INJECTION
Approval history
2002-11-07Manufacturing (CMC) · Supplement 24AP
2002-11-07Labeling · Supplement 22AP
2002-11-07Manufacturing (CMC) · Supplement 23AP
2002-11-07Manufacturing (CMC) · Supplement 21AP
1998-11-16Labeling · Supplement 20AP
1997-09-25Manufacturing (CMC) · Supplement 19AP
1994-08-24Labeling · Supplement 16AP
1994-05-09Manufacturing (CMC) · Supplement 18AP
1994-05-09Manufacturing (CMC) · Supplement 17AP
1992-05-20Labeling · Supplement 12AP
1992-03-31Labeling · Supplement 13AP
1966-03-01OriginalAP
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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