APPLICATION
ANDA065148
TYPE
ANDA
ORIGINAL APPROVAL
2005-06-28
LATEST ACTION
2009-11-18
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Prescription
Products
NYSTATINPrescription
NYSTATIN 100,000 UNITS/ML · SUSPENSION · ORAL
Approval history
2009-11-18Labeling · Supplement 1AP
2005-06-28OriginalAP
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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