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FDA NDA · NDA021864

LYBREL

Sponsor: WYETH PHARMS INC

APPLICATION
NDA021864
TYPE
NDA
ORIGINAL APPROVAL
2007-05-22
LATEST ACTION
2016-06-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

LYBREL · ReferenceDiscontinued
ETHINYL ESTRADIOL 0.02MG, LEVONORGESTREL 0.09MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2016-06-16Labeling · Supplement 7 · standard — Label ↗AP
2015-12-31Manufacturing (CMC) · Supplement 5 · standardAP
2008-09-15Labeling · Supplement 2 · standard — Letter ↗AP
2007-05-22Type 5 - New Formulation or New Manufacturer · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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