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FDA NDA · NDA022474

ELLA

ulipristal acetate

Sponsor: LAB HRA PHARMA

APPLICATION
NDA022474
TYPE
NDA
ORIGINAL APPROVAL
2010-08-13
LATEST ACTION
2021-06-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ELLA · ReferencePrescription
ULIPRISTAL ACETATE 30MG · TABLET · ORAL

Approval history

2021-06-24Efficacy · Supplement 11 · standard — Letter ↗AP
2018-05-01Labeling · Supplement 10 · standard — Letter ↗AP
2015-04-07Manufacturing (CMC) · Supplement 6 · standardAP
2015-03-10Labeling · Supplement 7 · standard — Letter ↗AP
2014-08-28Labeling · Supplement 5 · standard — Label ↗AP
2014-06-27Manufacturing (CMC) · Supplement 3 · standardAP
2014-06-12Labeling · Supplement 4 · standard — Letter ↗AP
2012-05-02Labeling · Supplement 2 · standard — Label ↗AP
2010-08-13Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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