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Roxane Company Profile

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Summary for Applicant: Roxane

Patents:0
Tradenames:165
Ingredients:149
NDAs:283
Drug Master File Entries: (click here to view)3
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Roxane
CAPECITABINE
capecitabine
TABLET;ORAL200483-002Jul 14, 2016RXNo<disabled><disabled>
Roxane
DIPHENHYDRAMINE HYDROCHLORIDE
diphenhydramine hydrochloride
ELIXIR;ORAL080643-001Approved Prior to Jan 1, 1982DISCNNo<disabled><disabled>
Roxane
CLOPIDOGREL BISULFATE
clopidogrel bisulfate
TABLET;ORAL078004-001May 17, 2012RXNo<disabled><disabled>
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