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FDA ANDA · ANDA062474

NYSTATIN

Sponsor: HERITAGE

APPLICATION
ANDA062474
TYPE
ANDA
ORIGINAL APPROVAL
1983-12-22
LATEST ACTION
2012-11-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

NYSTATINPrescription
NYSTATIN 500,000 UNITS · TABLET · ORAL

Approval history

2012-11-01Manufacturing (CMC) · Supplement 10AP
1997-10-29Manufacturing (CMC) · Supplement 6AP
1997-07-11Labeling · Supplement 9AP
1993-12-15Manufacturing (CMC) · Supplement 8AP
1993-12-15Manufacturing (CMC) · Supplement 7AP
1983-12-22OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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