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DEPARTMENT OF HEALTH & HIJMAN SERVICES Food and Drug Administration Rockville, MD[removed]WARNING LETTER February 26, 2007
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City

Rockville / Little Falls / /

Company

Actavis Totowa LLC / Ergotamine / Bellaspas Tablets / Belladonna Tablets / PB Tablets / Bellamine S Tablets / Divya C. Patel President Actavis Totowa LLC / Bel- Actavis Totowa LLC / Phenobarbital / Belladonna Alka Ergotamine / Sage Pharmaceuticals / /

Country

United States / /

Event

FDA Phase / /

Facility

Rockville Pike / /

/

IndustryTerm

to your products / unapproved ergotaminecontaining products / manufacturing / drug products / /

MedicalCondition

cephalalgia / migraine / seizure / migraine variants / vascular headaches / /

MedicalTreatment

antibiotics / /

Organization

Michael Levy Director Division of New Drugs / Food and Drug Administration / US Federal Reserve / Division of New Drugs and Labeling Compliance / Center for Drug Evaluation and Research / DEPARTMENT OF HEALTH / New Drugs and Labeling Compliance Office / /

Person

Michael Levy / Sally Loewke / Alka Ergotamine / /

/

Position

unapproved drugs coordinator / /

Product

Belladonna Tablets / Bellaspas Tablets / PB Tablets / Bellamine Tablets / new drug / S / /

ProvinceOrState

New Jersey / Maryland / /

URL

www .fda.~ov/cder/re~Zlator / /

SocialTag