← FDA DRUG APPROVALS

FDA NDA · NDA203159

SKYLA

levonorgestrel

Sponsor: BAYER HLTHCARE

APPLICATION
NDA203159
TYPE
NDA
ORIGINAL APPROVAL
2013-01-09
LATEST ACTION
2023-05-04
ROUTE
INTRAUTERINE
DOSAGE FORM
SYSTEM
MARKETING STATUS
Prescription

Products

SKYLA · ReferencePrescription
LEVONORGESTREL 13.5MG · SYSTEM · INTRAUTERINE

Approval history

2023-05-04Labeling · Supplement 14 · standard — Letter ↗AP
2022-01-12Labeling · Supplement 13 · standard — Letter ↗AP
2021-05-17Labeling · Supplement 12 · standard — Label ↗AP
2018-03-01Labeling · Supplement 10 · standard — Label ↗AP
2017-03-03Labeling · Supplement 7 · standard — Label ↗AP
2016-12-21Labeling · Supplement 8 · standard — Label ↗AP
2016-11-02Labeling · Supplement 6 · standard — Letter ↗AP
2016-04-08Labeling · Supplement 5 · standard — Label ↗AP
2014-05-08Manufacturing (CMC) · Supplement 3 · standardAP
2013-09-13Labeling · Supplement 2 · standard — Letter ↗AP
2013-08-07Labeling · Supplement 1 · standard — Letter ↗AP
2013-01-09Type 5 - New Formulation or New Manufacturer · Original · standard — Summary Review ↗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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