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`DEPARTMENT OF HEALTH & HUMAN SERVICES
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`Public Health Service
`Food and Drug Administration
`Rockville, MD 20857
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`NDA 17-694/S-050
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`McNeil Consumer & Specialty Pharmaceuticals
`Attn: Hina S. Wu, Pharm.D.
`7050 Camp Hill Road
`Fort Washington, PA 19034
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`Dear Dr. Wu:
`
`Please refer to your supplemental new drug application dated April 20, 2005, received
`April 22, 2005, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for
`Imodium® (loperamide HCL) Capsule, 2 mg.
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`Your submission of April 20, 2005 constituted a complete response to our December 21, 2004 action
`letter.
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`This supplemental new drug application provides for revised labeling in response to our
`December 21, 2004, approvable letter.
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`We completed our review of this application. This application is approved, effective on the date of this
`letter, for use as recommended in the agreed-upon labeling text and with the minor editorial revisions
`indicated in the enclosed labeling.
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`The final printed labeling (FPL) must be identical, and include the minor editorial revisions indicated
`in the enclosed labeling text for the package insert. These revisions are terms of the approval of this
`application.
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`Please submit an electronic version of the FPL according to the guidance for industry titled Providing
`Regulatory Submissions in Electronic Format - NDA. Alternatively, you may submit 20 paper copies
`of the FPL as soon as it is available but no more than 30 days after it is printed. Individually mount 15
`of the copies on heavy-weight paper or similar material. For administrative purposes, designate this
`submission "FPL for approved supplement NDA 17-694/S-050.” Approval of this submission by
`FDA is not required before the labeling is used.
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`NDA 17-694/S-050
`Page 2
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`We remind you that you must comply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
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`If you have any questions, call Giuseppe Randazzo, Regulatory Project Manager, at (301) 796-0980.
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`Sincerely,
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`{See appended electronic signature page}
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`Brian E. Harvey, M.D. Ph.D.
`Director
`Division of Gastroenterology Products
`Office of Drug Evaluation III
`Center for Drug Evaluation and research
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`Enclosure
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`---------------------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed electronically and
`this page is the manifestation of the electronic signature.
`---------------------------------------------------------------------------------------------------------------------
` /s/
`---------------------
`Joyce Korvick
`10/21/2005 02:41:59 PM
`for Dr. Brian Harvey
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