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FDA ANDA · ANDA061966

NYSTATIN

nystatin cream

Sponsor: COSETTE PHARMS NC

APPLICATION
ANDA061966
TYPE
ANDA
ORIGINAL APPROVAL
1976-05-25
LATEST ACTION
2001-08-30
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription

Products

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

Approval history

2001-08-30Manufacturing (CMC) · Supplement 25AP
1996-06-13Manufacturing (CMC) · Supplement 24AP
1995-05-04Manufacturing (CMC) · Supplement 23AP
1995-05-04Manufacturing (CMC) · Supplement 22AP
1993-12-03Manufacturing (CMC) · Supplement 21AP
1993-12-03Manufacturing (CMC) · Supplement 18AP
1993-12-03Manufacturing (CMC) · Supplement 20AP
1993-12-03Manufacturing (CMC) · Supplement 19AP
1993-10-21Manufacturing (CMC) · Supplement 15AP
1993-10-21Manufacturing (CMC) · Supplement 13AP
1993-10-21Manufacturing (CMC) · Supplement 14AP
1993-10-21Manufacturing (CMC) · Supplement 12AP
1993-08-31Manufacturing (CMC) · Supplement 16AP
1993-08-31Manufacturing (CMC) · Supplement 17AP
1993-08-09Manufacturing (CMC) · Supplement 10AP
1993-04-27Labeling · Supplement 11AP
1992-11-10Manufacturing (CMC) · Supplement 8AP
1992-09-25Labeling · Supplement 9AP
1976-05-25OriginalAP
VIEW ON DRUGS@FDA ↗

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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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