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Lactams / Organofluorides / Organic chemistry / Neurology / Hypnotics / Quazepam / Triazolam / Insomnia / Flunitrazepam / Organochlorides / Benzodiazepines / Chemistry


DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring, MD 20993
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City

Beltsville / Reference / Monmouth Junction / /

Company

Sciecure Pharma / PhD President Sciecure Pharma Inc. / BCPS / PharmD / PhD Sciecure Pharma / /

Event

FDA Phase / Product Issues / Product Recall / /

/

IndustryTerm

treatment of insomnia / healthcare professionals / drug product / prescription drug product / /

MedicalCondition

acute and chronic insomnia / insomnia / several other disorders / headache / next-day psychomotor impairment / benzodiazepine withdrawal syndrome / pulmonary insufficiency / fatigue / daytime drowsiness / hypersensitivity / dizziness / chronic insomnia / depression / suspected sleep apnea / /

MedicalTreatment

Pharmacotherapy / /

Organization

Food and Drug Administration / U.S. Food and Drug Administration / DOSAGE AND ADMINISTRATION / office of Prescription Drug Promotion / Center for Drug Evaluation and Research / DEPARTMENT OF HEALTH / /

Person

MATHILDA K FIENKENG / Silver Spring / Mathilda Fienkeng / Wang / Melinda McLawhorn / /

Position

Team Leader / Regulatory Review Officer / /

Product

syndrome / DORAL / triazolam / Doral tablets / DORALĀ® (quazepam) Tablets / activities / /

ProvinceOrState

New Jersey / Maryland / /

Technology

pharmacokinetics / pharmacodynamics / /

SocialTag