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Medicine / Pharmaceutical sciences / Health / Drug safety / Abbreviated New Drug Application / New Drug Application / Generic drug / Federal Food / Drug / and Cosmetic Act / Food and Drug Administration / Pharmaceuticals policy / Pharmaceutical industry


Venable, Baetjer, Howard & Civileti, L.L.P. Attention: Geoffrey M. Levitt, Esq[removed]New York Ave, NW, Suite 1000 Washington, DC[removed]Docket No. OZP-OK%/‘CPf Dear Mr. Levitt:
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Document Date: 2001-12-19 09:34:32

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File Size: 399,88 KB

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City

Washington / DC / Rockville / /

Company

Branch / Bristol-Myers Squibb Company / Gary J. Buehler / Venable / Howard & Civileti L.L.P. / /

Currency

pence / /

Event

FDA Phase / /

Facility

Pha~aceut~~a~ Research Institute / /

IndustryTerm

proposed drug products / above-referenced drug products / ready-to-use solution / listed drug products / drug products / listed reference drug products / listed drug product / /

Organization

office of Generic Drugs / Pha~aceut~~a~ Research Institute / Division of Bioequivalence / office of Generic Drugs Center for Drug Evaluation and Research / /

Person

Geoffrey M. Levitt / /

Position

Director / /

Product

Carboplatin / Carboplatin Injection / aI1 / /

ProgrammingLanguage

DC / /

ProvinceOrState

Maryland / /

SocialTag