← FDA DRUG APPROVALS

FDA NDA · NDA012911

METOPIRONE

metyrapone

Sponsor: ESTEVE

APPLICATION
NDA012911
TYPE
NDA
ORIGINAL APPROVAL
1961-12-04
LATEST ACTION
2023-07-25
ROUTE
ORAL
DOSAGE FORM
CAPSULE, TABLET
MARKETING STATUS
Prescription, Discontinued

Products

METOPIRONE · ReferencePrescription
METYRAPONE 250MG · CAPSULE · ORAL
METOPIRONEDiscontinued
METYRAPONE 250MG · TABLET · ORAL

Approval history

2023-07-25Labeling · Supplement 39 · standard — Letter ↗AP
2022-09-08Labeling · Supplement 38 · standard — Letter ↗AP
2020-02-20Labeling · Supplement 36 · standard — Letter ↗AP
2018-10-22Labeling · Supplement 35 · standard — Letter ↗AP
2014-08-14Manufacturing (CMC) · Supplement 34 · priorityAP
2013-09-20Manufacturing (CMC) · Supplement 32 · priorityAP
2013-09-05Manufacturing (CMC) · Supplement 33 · priority — Label ↗AP
2013-06-28Manufacturing (CMC) · Supplement 31 · priorityAP
2013-01-19Manufacturing (CMC) · Supplement 30 · priorityAP
2010-11-04Labeling · Supplement 26 · standard — Label ↗AP
2004-05-07Labeling · Supplement 23 · standard — Letter ↗AP
1999-04-21Manufacturing (CMC) · Supplement 20 · priorityAP
1999-02-09Manufacturing (CMC) · Supplement 19 · priorityAP
1996-06-27Manufacturing (CMC) · Supplement 18 · priorityAP
1995-08-09Manufacturing (CMC) · Supplement 17 · priorityAP
1992-06-12Manufacturing (CMC) · Supplement 16 · priorityAP
1992-03-26Manufacturing (CMC) · Supplement 14 · priorityAP
1992-03-13Labeling · Supplement 15AP
1986-02-10Labeling · Supplement 13AP
1986-01-10Labeling · Supplement 12AP
1984-08-29Manufacturing (CMC) · Supplement 11 · priorityAP
1983-01-17Labeling · Supplement 10AP
1978-02-03Manufacturing (CMC) · Supplement 9 · priorityAP
1976-03-02Labeling · Supplement 8AP
1961-12-04Type 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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