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FDA NDA · NDA208224

KYLEENA

levonorgestrel

Sponsor: BAYER HLTHCARE

APPLICATION
NDA208224
TYPE
NDA
ORIGINAL APPROVAL
2016-09-16
LATEST ACTION
2023-05-04
ROUTE
INTRAUTERINE
DOSAGE FORM
SYSTEM
MARKETING STATUS
Prescription

Products

KYLEENA · ReferencePrescription
LEVONORGESTREL 19.5MG · SYSTEM · INTRAUTERINE

Approval history

2023-05-04Labeling · Supplement 5 · standard — Letter ↗AP
2022-01-10Labeling · Supplement 4 · standard — Letter ↗AP
2021-04-13Labeling · Supplement 2 · standard — Label ↗AP
2018-03-01Labeling · Supplement 1 · standard — Label ↗AP
2016-09-16Type 5 - New Formulation or New Manufacturer · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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