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Profile for Applicant: Sanofi Aventis Us

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Summary for Applicant: Sanofi Aventis Us

Drug Master File Entries: (click here to view)134
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis Us
fexofenadine hydrochloride
SUSPENSION;ORAL021963-001Oct 16, 2006RXYes7,138,524*PED<disabled> <disabled>
Sanofi Aventis Us
imipramine hydrochloride
TABLET;ORAL011836-003Approved Prior to Jan 1, 1982DISCNNo<disabled><disabled>
Sanofi Aventis Us
TABLET;ORAL020757-003Sep 30, 1997RXYes6,342,247*PED<disabled>Y<disabled>
Sanofi Aventis Us
FILM, EXTENDED RELEASE;TRANSDERMAL020165-006Aug 2, 1996OTCYes8,075,911<disabled>Y <disabled>
Sanofi Aventis Us
INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS201739-001Aug 10, 2012RXNo8,206,360<disabled>Y <disabled>
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Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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