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FDA ANDA · ANDA062506

NYSTATIN

Sponsor: TEVA

APPLICATION
ANDA062506
TYPE
ANDA
ORIGINAL APPROVAL
1984-01-16
LATEST ACTION
2001-08-30
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

NYSTATINPrescription
NYSTATIN 500,000 UNITS · TABLET · ORAL

Approval history

2001-08-30Manufacturing (CMC) · Supplement 39AP
2000-07-07Manufacturing (CMC) · Supplement 38AP
1999-12-21Manufacturing (CMC) · Supplement 37AP
1998-03-09Manufacturing (CMC) · Supplement 36AP
1997-08-19Manufacturing (CMC) · Supplement 35AP
1997-06-05Manufacturing (CMC) · Supplement 34AP
1997-04-02Labeling · Supplement 33AP
1997-01-07Manufacturing (CMC) · Supplement 30AP
1996-11-26Manufacturing (CMC) · Supplement 32AP
1996-10-04Manufacturing (CMC) · Supplement 31AP
1996-08-16Manufacturing (CMC) · Supplement 29AP
1996-01-25Manufacturing (CMC) · Supplement 28AP
1996-01-25Manufacturing (CMC) · Supplement 26AP
1996-01-25Manufacturing (CMC) · Supplement 27AP
1995-03-02Manufacturing (CMC) · Supplement 24AP
1995-02-10Manufacturing (CMC) · Supplement 25AP
1994-02-09Labeling · Supplement 23AP
1994-01-14Manufacturing (CMC) · Supplement 18AP
1994-01-14Manufacturing (CMC) · Supplement 22AP
1994-01-14Manufacturing (CMC) · Supplement 20AP
1994-01-14Manufacturing (CMC) · Supplement 19AP
1994-01-14Manufacturing (CMC) · Supplement 17AP
1994-01-14Manufacturing (CMC) · Supplement 21AP
1993-12-03Manufacturing (CMC) · Supplement 16AP
1993-12-03Manufacturing (CMC) · Supplement 14AP
1993-12-03Labeling · Supplement 15AP
1993-12-03Manufacturing (CMC) · Supplement 8AP
1993-08-31Manufacturing (CMC) · Supplement 12AP
1993-08-31Manufacturing (CMC) · Supplement 13AP
1993-04-01Manufacturing (CMC) · Supplement 11AP
1993-04-01Manufacturing (CMC) · Supplement 9AP
1993-04-01Manufacturing (CMC) · Supplement 10AP
1984-01-16OriginalAP
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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