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FDA NDA · NDA021045

PLAN B

Sponsor: FDN CONSUMER

APPLICATION
NDA021045
TYPE
NDA
ORIGINAL APPROVAL
1999-07-28
LATEST ACTION
2024-03-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

PLAN B · ReferenceDiscontinued
LEVONORGESTREL 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
PLAN B · ReferenceDiscontinued
LEVONORGESTREL 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2024-03-21Labeling · Supplement 18 · standard — Letter ↗AP
2018-04-24Labeling · Supplement 17 · standard — Letter ↗AP
2017-09-28Labeling · Supplement 16 · standard — Label ↗AP
2009-07-10Efficacy · Supplement 15 · standard — Letter ↗AP
2006-08-24Efficacy · Supplement 11 · unknown — Letter ↗AP
2002-06-21Manufacturing (CMC) · Supplement 8 · priorityAP
2002-02-13Manufacturing (CMC) · Supplement 7 · priorityAP
2001-02-28Manufacturing (CMC) · Supplement 6 · priorityAP
2000-12-13Manufacturing (CMC) · Supplement 5 · priorityAP
2000-06-30Manufacturing (CMC) · Supplement 3 · priorityAP
2000-05-24Manufacturing (CMC) · Supplement 4 · priorityAP
2000-04-12Manufacturing (CMC) · Supplement 2 · priorityAP
2000-03-28Manufacturing (CMC) · Supplement 1 · priorityAP
1999-07-28Type 3 - New Dosage Form and Type 4 - New Combination · Original · priority — Review ↗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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