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Pharmaceutical sciences / Pharmaceutical industry / Medical informatics / Drug safety / Pharmaceuticals policy / Structured Product Labeling / New Drug Application / Packaging and labeling / Package insert / Medicine / Food and Drug Administration / Health


Zyclara (imiquimod) cream
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Document Date: 2011-03-25 10:06:47

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File Size: 58,05 KB

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City

Reference / Bristol / /

Company

S-001 NDA APPROVAL Graceway Pharmaceuticals LLC / NDA APPROVAL Graceway Pharmaceuticals / LLC / /

Event

FDA Phase / /

IndustryTerm

proposed introductory advertising / drug product / age / /

MedicalCondition

perianal warts / /

Organization

Food and Drug Administration Center for Drug Evaluation / F.A.A.D. Director Division of Dermatology / Food and Drug Administration / DEPARTMENT OF HEALTH AND HUMAN SERVICES / Dermatology and Dental Products Office / Research Division of Drug Marketing / Advertising / and Communications / Division of Drug Marketing / Advertising / and Communications / /

Person

SUSAN J WALKER / Sean Brennan / Silver Spring / Susan J. Walker / Cristina Attinello / /

/

Position

King / Regulatory Project Manager / Senior Vice President / Regulatory Affairs / /

Product

S-001 / Zyclara (imiquimod) Cream / /

ProvinceOrState

Tennessee / Maryland / /

Technology

pdf / /

URL

http /

SocialTag