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DRUG ADMINISTRATION APPLICATION TO MARKET A NEW DRUG, BIOLOGIC, OR AN ANTIBIOTIC DRUG FOR HUMAN USE FOR FDA USE ONLY APPLICATION NUMBER (Title 21, Code of Federal Regulations, Parts 314 & 601) APPLICANT INFORMATION NAME OF APPLICANT DATE OF SUBMISSION TELEPHONE NO. (Include Area Code) FACSIMILE (FAX) Number (Include Area Code) APPLICANT ADDRESS (Number, Street, City, State, Country, ZIP Code or Mail Code, and U.S. License Number if previously issued): AUTHORIZED U.S. AGENT NAME & ADDRE.

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