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Steroid hormones / Progestagens / Obstetrics / Neurosteroids / Progesterone / Preterm birth / Fertility / 17-Hydroxyprogesterone caproate / 17-Hydroxyprogesterone / Endocrine system / Reproduction / Medicine


Background Document for Meeting of Advisory Committee for Reproductive Health Drugs January 20, 2012 NDA[removed]Progesterone gel (8%)
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Company

Definitions AE / Columbia Laboratories Inc. / ITT / /

Country

United States / /

Event

FDA Phase / /

Facility

Laboratory Findings / /

MedicalCondition

preterm births / PROM / preterm labor / OF CHORIOAMNIONITIS / deficiency / preterm birth / OF PRETERM BIRTH / spontaneous preterm birth / /

MedicalTreatment

Assisted Reproductive Technology / /

Organization

Urologic Products Office / Advisory Committee for Reproductive Health Drugs / Reproductive and Urologic Products Office / New Drugs Center for Drug Evaluation / Food and Drug Administration / Advisory Committee / Review Division / Division of Reproductive / /

Position

pathologist / /

Product

hydroxyprogesterone caproate / COL-1620-302 / COL-1620-300 / fetal / TABLE / Progesterone gel / Progesterone / /

Technology

ultrasound / Pharmacodynamics / diagnostic tests / drug development / /

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