FDA NDA · NDA202107

MIFEPRISTONE

Sponsor: CORCEPT THERAP

APPLICATION

NDA202107

TYPE

NDA

ORIGINAL APPROVAL

2012-02-17

LATEST ACTION

2019-11-05

ROUTE

ORAL

DOSAGE FORM

TABLET

MARKETING STATUS

Prescription

Products

KORLYM · ReferencePrescription

MIFEPRISTONE 300MG · TABLET · ORAL

2019-11-05Labeling · Supplement 8 · standard — Letter ↗AP

2017-05-16Labeling · Supplement 7 · standard — Label ↗AP

2016-10-25Labeling · Supplement 6 · standard — Letter ↗AP

2015-07-22Manufacturing (CMC) · Supplement 5 · standardAP

2014-07-29Manufacturing (CMC) · Supplement 4 · standardAP

2014-07-28Manufacturing (CMC) · Supplement 3 · standardAP

2013-10-03Manufacturing (CMC) · Supplement 2 · standardAP

2012-02-17Type 5 - New Formulation or New Manufacturer · Original · standard — Review ↗AP

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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