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FDA NDA · NDA021998

PLAN B ONE-STEP

levonorgestrel

Sponsor: FDN CONSUMER

APPLICATION
NDA021998
TYPE
NDA
ORIGINAL APPROVAL
2009-07-10
LATEST ACTION
2022-12-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Over-the-counter

Products

PLAN B ONE-STEP · ReferenceOver-the-counter
LEVONORGESTREL 1.5MG · TABLET · ORAL

Approval history

2022-12-23Labeling · Supplement 5 · standard — Letter ↗AP
2019-01-04Labeling · Supplement 6 · standard — Label ↗AP
2017-08-10Labeling · Supplement 4 · standard — Label ↗AP
2013-06-20Efficacy · Supplement 3 · standard — Letter ↗AP
2013-04-30Efficacy · Supplement 2 · standard — Label ↗AP
2009-07-10Type 3 - New Dosage Form · 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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