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| Dockets Entered
On July 14, 2006
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| Docket #
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| Title
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| 2004P-0557
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| ANDA for a generic version of Efudex Cream(fluorouracil) cream
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| 2005N-0437
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| Medical Gas Containers and Closures; Current Good Manufacturing
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| 2005P-0300
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| Determine that the drug Phenergan (promethazine hydrochloride) 12.5 mg and 50 mg tablets (NDA 07-935) was voluntarily withdrawn from sale for reasons other than safety or effectiveness
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| 2005P-0319
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| Determination of PHENERGAN (Promethazine hydrochloride) 12.5mg and 50mg tablets
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| 2006N-0266
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| Denial of Request for Change in Classification of Breathing Frequenty Monitor and Electroencephalograph
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| 2006P-0090
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| Immediately begin the phased removal from the market of propoxyphene (Darvon) and all propoxyphene-containing products.
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| 2006P-0151
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| Stay the current approvable letter with conditions of any and all Premarket Applications for silicone gel-filled breast implants
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| 2004P-0557
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| ANDA for a generic version of Efudex Cream(fluorouracil) cream
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| RC 3
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| Valeant Pharmaceuticals International
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| Vol #:
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| 3
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| 2005N-0437
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| Medical Gas Containers and Closures; Current Good Manufacturing
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| C 40
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| Gas Innovations
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| 3
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| C 41
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| Machine & Welding Supply Compony of Dunn, NC
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| 3
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| 2005P-0300
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| Determine that the drug Phenergan (promethazine hydrochloride) 12.5 mg and 50 mg tablets (NDA 07-935) was voluntarily withdrawn from sale for reasons other than safety or effectiveness
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| N 1
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| FDA
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| 1
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| N 2
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| Number not used
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| 1
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| 2005P-0319
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| Determination of PHENERGAN (Promethazine hydrochloride) 12.5mg and 50mg tablets
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| N 1
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| FDA
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| 1
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| 2006N-0266
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| Denial of Request for Change in Classification of Breathing Frequenty Monitor and Electroencephalograph
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| ND 1
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| FDA
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| 1
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| 2006P-0090
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| Immediately begin the phased removal from the market of propoxyphene (Darvon) and all propoxyphene-containing products.
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| SUP 2
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| Public Citizen's Health Research Group
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| 3
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| 2006P-0151
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| Stay the current approvable letter with conditions of any and all Premarket Applications for silicone gel-filled breast implants
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| EC 623
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| Ms. Elizabeth DeWitt
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| 3
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