← FDA DRUG APPROVALS

FDA NDA · NDA017557

DANOCRINE

Sponsor: SANOFI AVENTIS US

APPLICATION
NDA017557
TYPE
NDA
ORIGINAL APPROVAL
1976-06-21
LATEST ACTION
2011-12-20
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

DANOCRINEDiscontinued
DANAZOL 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
DANOCRINEDiscontinued
DANAZOL 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
DANOCRINEDiscontinued
DANAZOL 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL

Approval history

2011-12-20Labeling · Supplement 42 · priority — Letter ↗AP
2011-12-20Labeling · Supplement 40 · priority — Label ↗AP
2011-12-20Labeling · Supplement 39 · priority — Letter ↗AP
2011-12-20Labeling · Supplement 41 · priority — Letter ↗AP
2011-12-20Labeling · Supplement 33 · priority — Label ↗AP
1996-12-19Manufacturing (CMC) · Supplement 35 · priorityAP
1995-08-02Manufacturing (CMC) · Supplement 30 · priorityAP
1994-05-02Labeling · Supplement 32 · priorityAP
1994-01-28Labeling · Supplement 31 · priorityAP
1993-03-01Labeling · Supplement 29 · priorityAP
1990-07-05Labeling · Supplement 28 · priorityAP
1988-05-02Manufacturing (CMC) · Supplement 27 · priorityAP
1986-03-24Labeling · Supplement 26 · priorityAP
1985-01-29Labeling · Supplement 25 · priorityAP
1984-08-09Labeling · Supplement 22 · priorityAP
1984-08-09Labeling · Supplement 23 · priorityAP
1984-08-09Labeling · Supplement 21 · priorityAP
1982-11-01Labeling · Supplement 15 · priorityAP
1982-01-22Manufacturing (CMC) · Supplement 16 · priorityAP
1981-05-18Efficacy · Supplement 10 · priorityAP
1980-11-03Labeling · Supplement 14 · priorityAP
1980-09-02Efficacy · Supplement 6 · priorityAP
1980-06-03Manufacturing (CMC) · Supplement 12 · priorityAP
1980-05-29Manufacturing (CMC) · Supplement 13 · priorityAP
1980-03-31Manufacturing (CMC) · Supplement 11 · priorityAP
1979-10-25Manufacturing (CMC) · Supplement 9 · priorityAP
1978-05-31Manufacturing (CMC) · Supplement 5 · priorityAP
1978-03-23Manufacturing (CMC) · Supplement 3 · priorityAP
1978-03-14Labeling · Supplement 4 · priorityAP
1976-09-27Labeling · Supplement 1 · priorityAP
1976-06-21Type 1 - New Molecular Entity · Original · priorityAP
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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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