APPLICATION
NDA050341
TYPE
NDA
ORIGINAL APPROVAL
1971-06-02
LATEST ACTION
1997-01-17
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Discontinued
Products
FUNGIZONEDiscontinued
AMPHOTERICIN B 100MG/ML · SUSPENSION · ORAL
Approval history
1997-01-17Manufacturing (CMC) · Supplement 5AP
1996-09-11Manufacturing (CMC) · Supplement 4AP
1996-03-07Labeling · Supplement 3AP
1995-07-24Manufacturing (CMC) · Supplement 1AP
1971-06-02OriginalAP
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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