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Profile for Applicant: Sanofi

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Summary for Applicant: Sanofi

Drug Master File Entries: (click here to view)133
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Exclusivity Expiration
Sanofi Synthelabo
tiludronate disodium
Tablet; Oral020707MAR 07, 1997RXYes<disabled><disabled>
Sanofi Synthelabo
Emulsion; Topical008402Approved prior to Jan 1, 1982DISCNNo<disabled><disabled>
Sanofi Synthelabo
clopidogrel bisulfate
Tablet; Oral020839NOV 17, 1997RXYes6,429,210<disabled><disabled>
Sanofi Synthelabo
isoetharine mesylate
Aerosol, Metered; Inhalation012339Approved prior to Jan 1, 1982DISCNNo<disabled><disabled>
Injectable; Iv (Infusion)021492AUG 09, 2002RXNo<disabled><disabled>
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