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Medicine / Food and Drug Administration / Drug safety / Pharmaceutical industry / Carbinoxamine / New Drug Application / Over-the-counter drug / Federal Food / Drug / and Cosmetic Act / Drug Efficacy Study Implementation / Pharmaceuticals policy / Pharmaceutical sciences / Pharmacology


[removed]Federal Register / Vol. 71, No[removed]Friday, June 9, [removed]Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES
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Document Date: 2006-06-09 08:47:02

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File Size: 59,37 KB

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City

Rockville / Atlanta / Nicholasville / /

Company

Drug Administration [Docket No. 2004F–0546] Alltech Inc. / Alltech Inc. / Mikart Inc. / McNeil Laboratories / Marketed Unapproved Drugs CPG / Sage Pharmaceuticals / /

Country

United States / /

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Event

Product Recall / FDA Phase / Product Issues / Reorganization / /

Facility

Catnip Hill Pike / /

IndustryTerm

treatment of cold symptoms / distribution chain / notice that any product / Certain singleingredient carbinoxamine products / carbinoxamine-containing products / early timed-release technology / unapproved product / manufacturing products / unapproved carbinoxamine products / treatment of various allergy symptoms / firm manufacturing / food additive petition / unapproved products / decongestant products / carbinoxamine products / unlisted carbinoxamine products / vulnerable age / combination product / carbinoxamine product / manufacturing / carbinoxamine-containing product / combination products / chemical structure / food additive regulations / /

MedicalCondition

mild / uncomplicated allergic skin manifestations / vasomotor rhinitis / anaphylactic reactions / allergy / allergic conjunctivitis / seizure / urticaria / angioedema / allergic reactions / seasonal and perennial allergic rhinitis / cough / /

Organization

Enforcement Action Dates AGENCY / office of New Drugs / Division of Pulmonary and Allergy Products / Internal Revenue Service / National Academy / McNeil’s NDA / Food Additive Petition AGENCY / Congress / Nuclear Regulatory Commission / Division of Dockets Management / CETROTIDE AGENCY / Science/National Research Council / Division of New Drugs and Labeling Compliance / FDA / Department of Commerce / Center for Drug Evaluation and Research / office of Generic Drugs / Center for Veterinary Medicine / /

Person

Silver Spring / John Loh / Jeffrey Shuren / Stephen F. Sundlof / /

Position

Deputy Commissioner for Policy / chief executive officer / Assistant Commissioner for Policy / Governor / Director / Director of Patents and Trademarks / /

Product

petition / approval of the NDAs / Clistin / approval of NDA / Clistin Tablets / approval of the NDAs pertaining / Clistin CM / ammonium chloride / Carbinoxamine Products / carbinoxamine maleate / CETROTIDE / Federal Food / CM / Carbinoxamine / PROD1PC65 / IRS drug / /

ProvinceOrState

Kentucky / Maryland / Georgia / /

PublishedMedium

the DESI review / /

Technology

early timed-release technology / /

SocialTag