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Janssen Prods Company Profile

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Summary for Applicant: Janssen Prods

Drug Master File Entries: (click here to view)92
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Prods
darunavir ethanolate
TABLET;ORAL021976-005Dec 18, 2008RXNo6,037,157*PED<disabled>Y<disabled>
Janssen Prods
simeprevir sodium
CAPSULE;ORAL205123-001Nov 22, 2013RXYes9,040,562<disabled>YY <disabled>
Janssen Prods
cobicistat; darunavir ethanolate
TABLET;ORAL205395-001Jan 29, 2015RXYesRE43596*PED<disabled> <disabled>
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