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FDA ANDA · ANDA062949

NYSTATIN

Sponsor: ACTAVIS MID ATLANTIC

APPLICATION
ANDA062949
TYPE
ANDA
ORIGINAL APPROVAL
1988-06-13
LATEST ACTION
2002-10-03
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription

Products

NYSTATINPrescription
NYSTATIN 100,000 UNITS/GM · CREAM · TOPICAL

Approval history

2002-10-03Manufacturing (CMC) · Supplement 10AP
2001-10-15Manufacturing (CMC) · Supplement 6AP
2001-05-30Manufacturing (CMC) · Supplement 9AP
2000-11-15Manufacturing (CMC) · Supplement 8AP
2000-01-24Manufacturing (CMC) · Supplement 7AP
1998-06-01Manufacturing (CMC) · Supplement 5AP
1996-08-26Manufacturing (CMC) · Supplement 4AP
1995-07-05Manufacturing (CMC) · Supplement 3AP
1994-07-05Manufacturing (CMC) · Supplement 1AP
1994-07-05Labeling · Supplement 2AP
1988-06-13OriginalAP
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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