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FDA NDA · NDA010909

MIRADON

Sponsor: SCHERING

APPLICATION
NDA010909
TYPE
NDA
ORIGINAL APPROVAL
1957-04-05
LATEST ACTION
2007-12-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

MIRADONDiscontinued
ANISINDIONE 50MG · TABLET · ORAL

Approval history

2007-12-07Labeling · Supplement 7AP
2002-02-06Labeling · Supplement 13 · standard — Letter ↗AP
1995-01-12Manufacturing (CMC) · Supplement 11 · standardAP
1994-12-30Labeling · Supplement 10 · standardAP
1989-04-05Labeling · Supplement 9AP
1986-08-08Manufacturing (CMC) · Supplement 8 · standardAP
1981-11-18Manufacturing (CMC) · Supplement 6 · standardAP
1981-11-18Labeling · Supplement 5AP
1957-04-05Type 1 - New Molecular Entity · Original · standardAP
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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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