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Dockets Management

Dockets Entered On October 23, 2007
Docket # Title
1978N-0038 Sunscreen Drug Products
2000E-1252 Patent Extension Alamast #5,034,230
2003E-0418 Emend (Aprepitant), Patent Term Extension Application; U.S. Patent No. 5,719,147
2004E-0308 Patent Extension for RESTYLANE Injectable Gel (Polysaccharide Gel Composition), U.S. Patent No. 5,827,937
2006E-0022 Patent Extension Application for SYMLIN (pramlintide acetate), U.S. Patent No. 5,686,411
2006E-0025 Patent Extension Application for INCRELEX (mecasermin rDNA orgin injection), U.S. Patent No. 5,681,814
2006E-0042 Patent Extension Application for CUBICIN (daptomycin for injection), U.S. Patent No. 4,885,243
2006E-0189 Patent Extension Application for IPLEX (mecasermin rinfabate rDNA origin injection), U.S. Patent No. 5,681,818
2006E-0261 Patent Extension Application for EXJADE (deferasirox), U.S. Patent No. 6,465,504
2007D-0201 Guidance for Industry and Food and Drug Administration Staff; Premarket Notification (510(k)) Submissions for Medical Devices That Include Antimicrobial Agents
2007D-0290 Guidance for Industry: Cell Selection Devices for Point of Care Production of Minimally Manipulated Autologous Peripheral Blood Stem Cells (PBSCs)
2007N-0182 Agency Information Collection Activities; Proposed Collection; Comment Request; Information Program on Clinical Trials for Serious or Life-Threatening Diseases: Maintaining a Databank
2007N-0186 Petition to Request an Exemption from 100 Percent Identity Testing of Dietary Ingredients: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
2007N-0317 Agency Information Collection Activities; Proposed Collection; Comment Request, Guidance for Industry on Pharmacogenomic Data Submissions; Extension
2007N-0321 Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Evaluation of the Impact of Distraction on Consumer Understanding of Risk and Benefit Information in Direct
2007N-0356 BEHIND THE COUNTER AVAILABILITY OF CERTAIN DRUGS; Public Meeting
2007N-0382 Ramipril Capsules and 180-day generic drug exclusivity
2007P-0074 Over-the-Counter (OTC) Cough and Cold Drug Products for Children Under 6 Years of Age
2007P-0079 To sanction third party independent scientific analysis of zine gluconate (ZICAM) additional safety standards for the homeopathic industry
2007P-0235 Change the labeling requirements for eggs sold in the United States
2007P-0400 Formally ban unnaturally synthesized fluoride compounds sold for consumption through oral ingestion
2007P-0407 To permit the filling of a Abbreiated new drug application (ANDA) for Abacavir Sulfate Tablets 60 mg
1978N-0038 Sunscreen Drug Products
EC 2463 Mrs. Jane Whitten Vol #: 162
EXT 13 L'OREAL Vol #: 162
2000E-1252 Patent Extension Alamast #5,034,230
CEP 1 U.S. Patent and Trademark Office to Perkins Cole LLP Vol #: 1
2003E-0418 Emend (Aprepitant), Patent Term Extension Application; U.S. Patent No. 5,719,147
LET 6 U.S. Patent and Trademark Office to Merck & Co., Inc. Vol #: 1
2004E-0308 Patent Extension for RESTYLANE Injectable Gel (Polysaccharide Gel Composition), U.S. Patent No. 5,827,937
CEP 1 U.S. Patent and Trademark Office to Burns, Doane, Swecker & Mathis, LLP Vol #: 1
2006E-0022 Patent Extension Application for SYMLIN (pramlintide acetate), U.S. Patent No. 5,686,411
CEP 1 U.S. Patent and Trademark Office to Amylin Pharmaceuticals, Inc. Vol #: 1
2006E-0025 Patent Extension Application for INCRELEX (mecasermin rDNA orgin injection), U.S. Patent No. 5,681,814
CEP 1 U.S. Patent and Trademark Office to Heller Ehrmann, LLP Vol #: 1
2006E-0042 Patent Extension Application for CUBICIN (daptomycin for injection), U.S. Patent No. 4,885,243
CEP 1 U.S. Patent and Trademark Office to Cubist Pharmaceuticals, Inc. Vol #: 1
2006E-0189 Patent Extension Application for IPLEX (mecasermin rinfabate rDNA origin injection), U.S. Patent No. 5,681,818
CEP 1 U.S. Patent and Trademark Office to Foley & Lardner Vol #: 1
2006E-0261 Patent Extension Application for EXJADE (deferasirox), U.S. Patent No. 6,465,504
LET 6 U.S. Patent and Trademark Office to Novartis Vol #: 1
2007D-0201 Guidance for Industry and Food and Drug Administration Staff; Premarket Notification (510(k)) Submissions for Medical Devices That Include Antimicrobial Agents
C 4 American Academy of Orthopadic Surgeons (AAOS) Vol #: 1
2007D-0290 Guidance for Industry: Cell Selection Devices for Point of Care Production of Minimally Manipulated Autologous Peripheral Blood Stem Cells (PBSCs)
EC 3 Biosafe Vol #: 1
EC 4 On behalf of device company to remain anonymous Vol #: 1
EC 5 American Society for Apheresis Vol #: 1
2007N-0182 Agency Information Collection Activities; Proposed Collection; Comment Request; Information Program on Clinical Trials for Serious or Life-Threatening Diseases: Maintaining a Databank
EC 1 Mr. W. H. Boyd Vol #: 1
2007N-0186 Petition to Request an Exemption from 100 Percent Identity Testing of Dietary Ingredients: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
C 2 Bergstrom Nutrition Vol #: 1
EREG 2 T. DuBose Vol #: 1
2007N-0317 Agency Information Collection Activities; Proposed Collection; Comment Request, Guidance for Industry on Pharmacogenomic Data Submissions; Extension
EC 1 Boehringer Ingelheim Pharmaceuticals, Inc. Vol #: 1
2007N-0321 Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Evaluation of the Impact of Distraction on Consumer Understanding of Risk and Benefit Information in Direct
C 2 Pfizer Vol #: 1
C 3 Sanofi Aventis Vol #: 1
C 4 Wyeth Vol #: 1
EC 23 Pfizer, Inc. Vol #: 1
EC 24 AstraZeneca LP Vol #: 1
EC 25 Eli Lilly and Company Vol #: 1
EC 26 Families USA Vol #: 1
EC 27 Kaiser Permanente Center for Health Research Vol #: 1
EC 28 Pharmaceutical Research and Manufacturers of Ameri Vol #: 1
EC 29 Davidson & Company Vol #: 1
2007N-0356 Behind The Counter Availability of Certain Drugs; Public Meeting
EAPE 162 Elge, Inc. Vol #: 1
EAPE 163 National Community Pharmacists Association Vol #: 1
EAPE 164 FDA/CDER Vol #: 1
EAPE 165 FDA/CDER/DDI Vol #: 1
EAPE 166 PEGUS Research Vol #: 1
EAPE 167 National Community Pharmacists Association Vol #: 1
EAPE 168 National Women's Law Center Vol #: 1
EAPE 169 Society for Women's Health Research Vol #: 1
EAPE 170 Pinney Associates Vol #: 1
EAPE 171 sanofi-aventis Vol #: 1
EAPE 172 3D Communications Vol #: 1
EAPE 173 Bayer HealthCare Vol #: 1
EAPE 174 Healthcare Distribution Management Association Vol #: 1
EAPE 175 Drug Benefit Trends Vol #: 1
EAPE 176 Leesburg Pharmacy Vol #: 1
EAPE 177 Covington & Burling LLP Vol #: 1
EAPE 178 FDA Vol #: 1
EAPE 179 Planned Parenthood Health Systems, Inc. Vol #: 1
EAPE 180 Planned Parenthood Health Systems, Inc. Vol #: 1
EAPE 181 CVS Caremark Vol #: 1
EAPE 182 Harbor-UCLA Medical Center Vol #: 1
EAPE 183 PCMA Vol #: 1
EC 19 Dr. Michele Kaufman Vol #: 1
EC 20 Ms. Katelyn Nicolosi Vol #: 1
EC 21 Dr. Charles Bonanno Vol #: 1
EC 22 Dr. APRIL SMITH Vol #: 1
EC 23 Mrs. Sue Walter Vol #: 1
EC 24 Ms. Monique Baran Vol #: 1
2007N-0382 Ramipril Capsules and 180-day generic drug exclusivity
C 1 Arent Fox Vol #: 1
C 2 Ranbaxy, Inc. Vol #: 1
C 3 FOLEY & LARDNER LLP Vol #: 1
EC 1 Express Scripts, Inc. Vol #: 1
EC 2 Apotex Vol #: 1
EC 3 Pharmaceutical Care Management Association Vol #: 1
2007P-0074 Over-the-Counter (OTC) Cough and Cold Drug Products for Children Under 6 Years of Age
EC 17 Ms. Kathleen Corcoran Vol #: 1
2007P-0079 To sanction third party independent scientific analysis of zine gluconate (ZICAM) additional safety standards for the homeopathic industry
SUP 2 D. Richardson Vol #: 1
2007P-0235 Change the labeling requirements for eggs sold in the United States
C 199 C. Graeff Vol #: 2
C 200 A. Robb Vol #: 2
C 201 M. Neese Vol #: 2
C 202 J. Mantooth Vol #: 2
C 203 L. Wapner Vol #: 2
C 204 Unknown Vol #: 2
C 205 M. Kagy Vol #: 2
C 206 B. Burns Vol #: 2
C 207 W. Wilson Vol #: 2
C 208 E. Schaefer Vol #: 2
2007P-0400 Formally ban unnaturally synthesized fluoride compounds sold for consumption through oral ingestion
EC 1 Ms. Dorothy Davis Vol #: 1
2007P-0407 To permit the filling of a Abbreiated new drug application (ANDA) for Abacavir Sulfate Tablets 60 mg
ACK 1 FDA/ DDM/ to Matrix Laboratories, Inc. Vol #: 1
CP 1 Matrix Laboratories, Inc. Vol #: 1

Page created on October 23, 2007 ue

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