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Dockets Management

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2005P-0436
CP 1
Volume 1

Citizen Petition

Tab A - Approved Drug Products with Therapeutic Equivalence Evaluation, 25th Edition (2005)(The Orange Book) information for Ibuprofen Oral Capsules 200 mg

Tab B - Approved Drug Products with Therapeutic Equivalence Evaluation, 25th Edition (2005)(The Orange Book) information for Banner's Ibuprofen Oral Capsules 200 mg

Tab C - U.S. Patent No. 6,251,426

Tab D - Ranbaxy’s letter to FDA, May 10, 2005

Tab E - Notification of certification sent by Ranbaxy to Banner, March 4, 2005

Tab F - Buc & Beardsley letter of September 20, 2005

Tab G - Banner Pharmacaps, Inc. v. Ranbaxy Laboratories (North Carolina) Civil Action 1:05CV00346

Tab H - Guidance for Industry - Applications Covered by Section 505(b)(2)

Tab I - FDA Ruling, Docket No. 2004P-0386, Nov. 30, 2004


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Page last updated November 9, 2005 RSChorizonal rule
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