← FDA DRUG APPROVALS

FDA NDA · NDA206229

LILETTA

levonorgestrel

Sponsor: MEDICINES360

APPLICATION
NDA206229
TYPE
NDA
ORIGINAL APPROVAL
2015-02-26
LATEST ACTION
2023-06-29
ROUTE
INTRAUTERINE
DOSAGE FORM
SYSTEM
MARKETING STATUS
Prescription

Products

LILETTA · ReferencePrescription
LEVONORGESTREL 52MG · SYSTEM · INTRAUTERINE

Approval history

2023-06-29Efficacy · Supplement 13 · standard — Letter ↗AP
2022-11-10Labeling · Supplement 11 · standard — Label ↗AP
2022-11-10Efficacy · Supplement 12 · standard — Label ↗AP
2020-04-27Labeling · Supplement 10 · standard — Label ↗AP
2019-10-25Efficacy · Supplement 8 · standard — Label ↗AP
2018-10-15Efficacy · Supplement 7 · standard — Letter ↗AP
2017-08-03Efficacy · Supplement 4 · standard — Label ↗AP
2016-05-31Manufacturing (CMC) · Supplement 2 · standardAP
2016-01-29Efficacy · Supplement 1 · standard — Label ↗AP
2015-02-26Type 5 - New Formulation or New Manufacturer · 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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