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Profile for Applicant: Smithkline Beecham

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Summary for Applicant: Smithkline Beecham

Drug Master File Entries: (click here to view)107
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Smithkline Beecham
TABLET, EXTENDED RELEASE; ORAL022115May 29, 2009RXYes<disabled><disabled>
Smithkline Beecham
topotecan hydrochloride
CAPSULE; ORAL020981Oct 11, 2007RXYes<disabled><disabled>
Smithkline Beecham
CAPSULE; ORAL019508Apr 12, 1988RXYes<disabled><disabled>
Smithkline Beecham
ropinirole hydrochloride
TABLET, EXTENDED RELEASE; ORAL022008Apr 10, 2009RXNo5,422,123<disabled>Y<disabled>
Smithkline Beecham
TABLET; ORAL020297Sep 14, 1995RXNoRE40000*PED<disabled><disabled>
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ISSN: 2162-2639

Preferred citation:

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

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