APPLICATION
ANDA062349
TYPE
ANDA
ORIGINAL APPROVAL
1982-07-14
LATEST ACTION
2001-10-17
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Discontinued
Products
NYSTATINDiscontinued
NYSTATIN 100,000 UNITS/ML · SUSPENSION · ORAL
Approval history
2001-10-17Manufacturing (CMC) · Supplement 31AP
1998-10-16Manufacturing (CMC) · Supplement 30AP
1997-06-03Labeling · Supplement 28AP
1997-05-08Manufacturing (CMC) · Supplement 27AP
1994-04-15Labeling · Supplement 26AP
1994-01-14Manufacturing (CMC) · Supplement 25AP
1993-07-08Labeling · Supplement 24AP
1992-11-09Manufacturing (CMC) · Supplement 23AP
1992-06-16Manufacturing (CMC) · Supplement 22AP
1991-07-24Manufacturing (CMC) · Supplement 17AP
1991-06-11Manufacturing (CMC) · Supplement 20AP
1990-09-28Manufacturing (CMC) · Supplement 21AP
1990-05-11Labeling · Supplement 18AP
1989-07-07Manufacturing (CMC) · Supplement 15AP
1989-01-26Manufacturing (CMC) · Supplement 14AP
1982-07-14OriginalAP
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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