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Organochlorides / Carboxylic acids / Piperazines / Pharmacokinetics / Levocetirizine / Cetirizine / Bioequivalence / H1 antagonist / Bioavailability / Chemistry / Organic chemistry / Ethers


CLINICAL PHARMACOLOGY REVIEW NDA: Type: Generic Name: Indication:
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Company

UCB Inc. / /

Country

United States / /

Event

FDA Phase / /

IndustryTerm

mL oral solution / dihydrochloride drug product / drug product / chemical name / levocetirizine dihydrochloride oral solution / mg oral solution / mg/mL oral solution / chemical structure / food / /

MedicalCondition

perennial allergic rhinitis / uncomplicated skin manifestations / allergic rhinitis / seasonal allergic rhinitis / chronic urticaria / chronic idiopathic urticaria / /

Organization

AND ADMINISTRATION / office of Clinical Pharmacology Division of Clinical Pharmacology / Clinical Division / DOSAGE AND ADMINISTRATION / FDA / OCP Division / office of Clinical Pharmacology / /

Person

Wei Qiu / Partha Roy / /

Position

Team Leader / Executive / General / QUESTION BASED REVIEW General / /

Product

DCP2 DPAP (OND-570) March 27 / Zyrtec / cetirizine hydrochloride / acetic acid / Xyzal / Xyzal® / DCP-2 / /

Technology

pharmacokinetics / /

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