APPLICATION
ANDA062519
TYPE
ANDA
ORIGINAL APPROVAL
1984-07-06
LATEST ACTION
1998-09-24
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Discontinued
Products
NYSTEXDiscontinued
NYSTATIN 100,000 UNITS/ML · SUSPENSION · ORAL
Approval history
1998-09-24Labeling · Supplement 6AP
1995-09-19Manufacturing (CMC) · Supplement 5AP
1995-03-10Manufacturing (CMC) · Supplement 1AP
1995-02-13Manufacturing (CMC) · Supplement 4AP
1993-10-08Labeling · Supplement 3AP
1993-08-18Labeling · Supplement 2AP
1984-07-06OriginalAP
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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