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FDA ANDA · ANDA062776

NYSTATIN

Sponsor: COSETTE PHARMS NC

APPLICATION
ANDA062776
TYPE
ANDA
ORIGINAL APPROVAL
1987-12-17
LATEST ACTION
2001-08-30
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Discontinued

Products

NYSTATINDiscontinued
NYSTATIN 100,000 UNITS/ML · SUSPENSION · ORAL

Approval history

2001-08-30Manufacturing (CMC) · Supplement 27AP
1997-08-19Manufacturing (CMC) · Supplement 26AP
1997-03-19Manufacturing (CMC) · Supplement 25AP
1996-04-12Manufacturing (CMC) · Supplement 24AP
1995-06-26Manufacturing (CMC) · Supplement 23AP
1995-06-26Manufacturing (CMC) · Supplement 21AP
1995-06-26Manufacturing (CMC) · Supplement 22AP
1995-05-04Manufacturing (CMC) · Supplement 20AP
1995-05-04Manufacturing (CMC) · Supplement 19AP
1994-02-09Labeling · Supplement 6AP
1993-12-03Manufacturing (CMC) · Supplement 18AP
1993-12-03Manufacturing (CMC) · Supplement 17AP
1993-10-21Manufacturing (CMC) · Supplement 15AP
1993-10-21Manufacturing (CMC) · Supplement 13AP
1993-10-21Manufacturing (CMC) · Supplement 11AP
1993-10-21Manufacturing (CMC) · Supplement 16AP
1993-10-21Manufacturing (CMC) · Supplement 14AP
1993-10-21Manufacturing (CMC) · Supplement 12AP
1993-04-01Manufacturing (CMC) · Supplement 9AP
1993-03-31Manufacturing (CMC) · Supplement 8AP
1993-03-31Manufacturing (CMC) · Supplement 7AP
1993-03-31Manufacturing (CMC) · Supplement 10AP
1992-06-01Manufacturing (CMC) · Supplement 4AP
1992-05-21Labeling · Supplement 5AP
1989-07-24Manufacturing (CMC) · Supplement 3AP
1987-12-17OriginalAP
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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