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Anatomy / Menstrual cycle / Ulipristal acetate / Progestagens / Emergency contraception / Selective progesterone receptor modulator / Progesterone / Ovulation / Estradiol / Endocrine system / Hormonal contraception / Human reproduction


22474 Ella Clinpharm PREA
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Company

Leon Pharma / HRA Pharma / Contents 1 / H RA Pharma / /

Country

Spain / /

Currency

pence / /

Event

FDA Phase / /

Facility

National Institute of Child Health / /

IndustryTerm

proposed manufacturing sites / drug product / food effect study / food intake / physical-chemical properties / food / /

MedicalCondition

colorless transparent aluminum foil blister / /

MedicalTreatment

emergency contraception / /

Organization

Concomitant administration / Required Office / Division of Clinical Pharmacology / US Federal Reserve / Human Development / National Institute of Child Health / HRA2914-511 Administration / Sponsor Division of Clinical Pharmacology / Division of Reproductive and Urologic Products / office of Clinical Pharmacology / National Institute of Child Health and Human Development / /

Person

Bryant Tran / Mehul U Mehta / Ronald Orleans / Myong-Jin Kim / Dionna Green / Ella Generic / Julia Cho / Nancy Hu / Gilbert Burckart / Kellie S Reynolds / Sally Choe / Lisa Soule / Nam Atiqur Rahman / Leon Farma / Hyunjin Kim / Pamela K Lucarelli / Darrell Abernethy / Kim Table / Christian Grimstein / Manoj Khurana / /

Position

Team Leader / Executive / General / Question Based Review General / M.S. Team Leader / /

Product

levonorgestrel / estradiol / Strength Tablet / Comparison - Micronized Tablet / Micronized Tablet vs. Unmicronized Capsule / HRA2914-476 / HRA2914-507 / HRA2914-512 / HRA2914-501 / HRA2914-509 / HRA2914-510 / /

Technology

ultrasound / /

SocialTag