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Extended cycle combined hormonal contraceptive / Hormonal contraception / Pharmacology / Pharmacometrics


N204061 Levo ee Clinical PREA
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City

Reference / /

Company

Teva / Teva Pharmaceutical Industries / /

Event

FDA Phase / /

IndustryTerm

manufacturing site / extended-cycle products / marketed extended-cycle product / /

MedicalCondition

breakthrough bleeding / /

MedicalTreatment

oral contraceptives / /

Organization

Division of Reproductive and Urologic Products Route of Administration / office of New Drugs / Division of Clinical Pharmacology / Clinical Pharmacology Review office of Clinical Pharmacology / EE OCP Division / /

Person

Myong-Jin Kim / Al Habet / Jeff Florian / Yaning Wang / /

Product

Levonorgestrel / estradiol / Seasonique / Seasonale / Seasonale® / ASC-301 / Seasonique® / strengths / LoSeasonique® / ASC-201 / /

Technology

pharmacokinetics / same technology / be formulated using the same technology / /

SocialTag