APPLICATION
ANDA060570
TYPE
ANDA
ORIGINAL APPROVAL
1964-11-12
LATEST ACTION
1995-10-06
ROUTE
TOPICAL
DOSAGE FORM
LOTION
MARKETING STATUS
Discontinued
Products
FUNGIZONEDiscontinued
AMPHOTERICIN B 3% · LOTION · TOPICAL
Approval history
1995-10-06Manufacturing (CMC) · Supplement 8AP
1993-05-03Manufacturing (CMC) · Supplement 7AP
1993-03-29Labeling · Supplement 6AP
1987-03-11Manufacturing (CMC) · Supplement 5AP
1986-12-02Manufacturing (CMC) · Supplement 4AP
1985-12-03Manufacturing (CMC) · Supplement 3AP
1983-07-06Manufacturing (CMC) · Supplement 2AP
1983-03-14Manufacturing (CMC) · Supplement 1AP
1964-11-12OriginalAP
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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