APPLICATION
ANDA064042
TYPE
ANDA
ORIGINAL APPROVAL
1994-02-28
LATEST ACTION
1998-10-22
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Discontinued
Products
NYSTATINDiscontinued
NYSTATIN 100,000 UNITS/ML · SUSPENSION · ORAL
Approval history
1998-10-22Manufacturing (CMC) · Supplement 5AP
1998-09-18Manufacturing (CMC) · Supplement 7AP
1998-09-18Labeling · Supplement 8AP
1998-02-23Manufacturing (CMC) · Supplement 6AP
1997-04-01Labeling · Supplement 4AP
1997-01-29Manufacturing (CMC) · Supplement 3AP
1996-04-25Manufacturing (CMC) · Supplement 2AP
1995-11-01Manufacturing (CMC) · Supplement 1AP
1994-02-28OriginalAP
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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