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FDA NDA · NDA021225

MIRENA

levonorgestrel

Sponsor: BAYER HLTHCARE

APPLICATION
NDA021225
TYPE
NDA
ORIGINAL APPROVAL
2000-12-06
LATEST ACTION
2022-08-12
ROUTE
INTRAUTERINE
DOSAGE FORM
SYSTEM
MARKETING STATUS
Prescription

Products

MIRENA · ReferencePrescription
LEVONORGESTREL 52MG · SYSTEM · INTRAUTERINE

Approval history

2022-08-12Efficacy · Supplement 43 · standard — Letter ↗AP
2021-08-11Efficacy · Supplement 42 · standard — Label ↗AP
2021-06-08Labeling · Supplement 36 · standard — Letter ↗AP
2021-05-26Labeling · Supplement 41 · standard — Letter ↗AP
2020-08-20Efficacy · Supplement 40 · standard — Label ↗AP
2017-06-08Efficacy · Supplement 38 · standard — Label ↗AP
2017-05-25Labeling · Supplement 39 · standard — Label ↗AP
2016-12-21Labeling · Supplement 37 · standard — Label ↗AP
2015-10-22Labeling · Supplement 31 · standard — Letter ↗AP
2014-12-08Manufacturing (CMC) · Supplement 35 · standardAP
2014-05-29Manufacturing (CMC) · Supplement 33 · standard — Review ↗AP
2014-05-08Manufacturing (CMC) · Supplement 34 · standardAP
2014-03-07Manufacturing (CMC) · Supplement 29 · standardAP
2013-08-07Labeling · Supplement 32 · standard — Letter ↗AP
2009-10-01Efficacy · Supplement 27 · priority — Letter ↗AP
2008-07-21Labeling · Supplement 19 · standard — Letter ↗AP
2008-06-02Labeling · Supplement 18 · standard — Letter ↗AP
2008-05-28Labeling · Supplement 17 · standard — Letter ↗AP
2004-01-08Labeling · Supplement 9 · standard — Letter ↗AP
2003-08-27Manufacturing (CMC) · Supplement 10 · standard — Letter ↗AP
2002-11-27Manufacturing (CMC) · Supplement 6 · standardAP
2002-03-29Manufacturing (CMC) · Supplement 4 · standardAP
2002-03-04Manufacturing (CMC) · Supplement 5 · standardAP
2001-12-05Manufacturing (CMC) · Supplement 3 · standardAP
2001-10-29Manufacturing (CMC) · Supplement 1 · standardAP
2001-10-12Labeling · Supplement 2 · standardAP
2000-12-06Type 3 - New Dosage Form · Original · standard — Pediatric Medical 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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