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FDA ANDA · ANDA060575

MYCOSTATIN

Sponsor: DELCOR ASSET CORP

APPLICATION
ANDA060575
TYPE
ANDA
ORIGINAL APPROVAL
1965-02-09
LATEST ACTION
1998-09-17
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Discontinued

Products

MYCOSTATINDiscontinued
NYSTATIN 100,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CREAM · TOPICAL

Approval history

1998-09-17Labeling · Supplement 8AP
1993-03-16Labeling · Supplement 12AP
1992-03-23Manufacturing (CMC) · Supplement 10AP
1991-09-11Manufacturing (CMC) · Supplement 11AP
1990-06-28Manufacturing (CMC) · Supplement 9AP
1965-02-09OriginalAP
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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