APPLICATION
ANDA064118
TYPE
ANDA
ORIGINAL APPROVAL
1996-08-16
LATEST ACTION
2002-11-13
ROUTE
TOPICAL
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription
Products
NYSTOPPrescription
NYSTATIN 100,000 UNITS/GM · POWDER · TOPICAL
Approval history
2002-11-13Manufacturing (CMC) · Supplement 11AP
2002-11-13Labeling · Supplement 12AP
2000-09-08Labeling · Supplement 10AP
1998-09-21Manufacturing (CMC) · Supplement 9AP
1998-09-21Manufacturing (CMC) · Supplement 8AP
1998-07-10Labeling · Supplement 5AP
1998-07-10Manufacturing (CMC) · Supplement 6AP
1998-07-10Manufacturing (CMC) · Supplement 4AP
1998-04-20Manufacturing (CMC) · Supplement 7AP
1997-07-30Manufacturing (CMC) · Supplement 3AP
1997-07-17Manufacturing (CMC) · Supplement 2AP
1997-02-10Manufacturing (CMC) · Supplement 1AP
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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