FDA NDA · NDA050619

MYCOSTATIN

Sponsor: DELCOR ASSET CORP

APPLICATION

NDA050619

TYPE

NDA

ORIGINAL APPROVAL

1987-04-09

LATEST ACTION

2003-04-30

ROUTE

ORAL

DOSAGE FORM

PASTILLE

MARKETING STATUS

Discontinued

Products

MYCOSTATINDiscontinued

NYSTATIN 200,000 UNITS · PASTILLE · ORAL

2003-04-30Labeling · Supplement 4 · standard — Letter ↗AP

1999-02-11Manufacturing (CMC) · Supplement 3 · standardAP

1998-11-13Labeling · Supplement 2 · standardAP

1994-04-26Labeling · Supplement 1 · standardAP

1987-04-09Type 3 - New Dosage Form · Original · standardAP

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.

Weekly Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.