← FDA DRUG APPROVALS

FDA NDA · NDA016885

LYSODREN

mitotane

Sponsor: ESTEVE

APPLICATION
NDA016885
TYPE
NDA
ORIGINAL APPROVAL
1970-07-08
LATEST ACTION
2024-10-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

LYSODREN · ReferencePrescription
MITOTANE 500MG · TABLET · ORAL

Approval history

2024-10-28Labeling · Supplement 33 · standard — Label ↗AP
2024-01-09Labeling · Supplement 32 · standard — Label ↗AP
2021-06-15Labeling · Supplement 29 · standard — Letter ↗AP
2017-05-09Labeling · Supplement 27 · standard — Label ↗AP
2016-03-11Labeling · Supplement 26 · standard — Label ↗AP
2013-11-15Labeling · Supplement 25 · standard — Letter ↗AP
2009-02-10Labeling · Supplement 23 · standard — Label ↗AP
2003-07-10Labeling · Supplement 22 · standard — Letter ↗AP
1999-03-29Manufacturing (CMC) · Supplement 21 · priorityAP
1997-09-04Labeling · Supplement 20 · standardAP
1992-01-08Manufacturing (CMC) · Supplement 18 · priorityAP
1987-07-01Labeling · Supplement 16AP
1987-04-02Manufacturing (CMC) · Supplement 14 · priorityAP
1986-09-29Manufacturing (CMC) · Supplement 7 · priorityAP
1986-07-21Manufacturing (CMC) · Supplement 12 · priorityAP
1986-06-30Labeling · Supplement 13AP
1985-12-24Labeling · Supplement 4AP
1985-09-20Labeling · Supplement 11AP
1985-08-26Manufacturing (CMC) · Supplement 8 · priorityAP
1985-08-06Manufacturing (CMC) · Supplement 10 · priorityAP
1978-11-28Manufacturing (CMC) · Supplement 5 · priorityAP
1978-04-24Manufacturing (CMC) · Supplement 3 · priorityAP
1970-07-08Type 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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