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Dockets Management

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Determine that the drug Phenergan (promethazine hydrochloride) 12.5 mg and 50 mg tablets (NDA 07-935) was voluntarily withdrawn from sale for reasons other than safety or effectiveness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Determine that the drug Phenergan (promethazine hydrochloride) 12.5 mg and 50 mg tablets (NDA 07-935) was voluntarily withdrawn from sale for reasons other than safety or effectiveness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

Page created on October 6, 2006 kk

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