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Pharmaceuticals policy / Food and Drug Administration / Drug safety / Pharmaceutical industry / Guaifenesin / Hydrocodone / Over-the-counter drug / New Drug Application / Generally recognized as safe and effective / Medicine / Pharmacology / Pharmaceutical sciences


Federal Register / Vol. 72, No[removed]Tuesday, May 29, [removed]Notices Dated: May 22, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–10271 Filed 5–25–07; 8:45 am] BILLING CODE 4160–01–S
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Document Date: 2007-05-29 07:40:56

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City

Rockville / Washington / DC / /

Company

Adams Laboratories Inc. / Marketed Unapproved Drugs CPG / Sage Pharmaceuticals / Adams Respiratory Therapeutics / /

Country

United States / /

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Event

FDA Phase / Name Change / Reorganization / /

Facility

Holiday Inn / Rockville Pike / /

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IndustryTerm

timed-release combination products / unapproved timedrelease products / notice that any product / unapproved timed-release guaifenesin products / drug product / unapproved product / obtained approved applications / time address products / unapproved products / timed-release drug products / Drug manufacturers / prescription products / timed-release products / individual applications / expectorant products / to all products / manufacturing / Firms submitting applications / unapproved drug products / drug products / timed-release guaifenesin products / /

MedicalCondition

allergies / Severely Active Crohn’s Disease / Allergy / seizure / cough / /

Organization

Gastrointestinal Drugs Advisory Committee / Enforcement Action Dates AGENCY / office of New Drugs / Division of Pulmonary and Allergy Products / Risk Management Advisory Committee / DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration / Drug Safety and Risk Management Advisory Committee / Division of Dockets Management / Division of New Drugs and Labeling Compliance / FDA / Center for Drug Evaluation and Research / office of Generic Drugs / Meeting AGENCY / /

Person

Silver Spring / Jeffrey Shuren / Sakineh Walther / /

Position

Deputy Commissioner for Policy / chief executive officer / Assistant Commissioner for Policy / Governor / /

Product

MUCINEX / acetaminophen / antitussive / TYSABRI / unapproved drug / OTC drug / /

ProgrammingLanguage

DC / /

ProvinceOrState

Maryland / /

PublishedMedium

the FDA Staff Manual Guide / /

Technology

http / /

URL

www.fda.gov/dockets/ecomments / /

SocialTag