APPLICATION
ANDA061533
TYPE
ANDA
ORIGINAL APPROVAL
1972-02-25
LATEST ACTION
1996-04-16
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Discontinued
Products
MYCOSTATINDiscontinued
NYSTATIN 100,000 UNITS/ML · SUSPENSION · ORAL
Approval history
1996-04-16Labeling · Supplement 18AP
1995-10-16Manufacturing (CMC) · Supplement 19AP
1994-01-11Manufacturing (CMC) · Supplement 17AP
1992-12-07Labeling · Supplement 16AP
1992-11-02Labeling · Supplement 15AP
1992-09-25Labeling · Supplement 11AP
1992-06-19Manufacturing (CMC) · Supplement 13AP
1990-08-21Labeling · Supplement 10AP
1988-03-29Manufacturing (CMC) · Supplement 9AP
1972-02-25OriginalAP
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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