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Dockets Management

Dockets Entered On March 26, 2007
Docket # Title
1998N-0337C Definition and Option of Alternative Labeling Requirements for Convenience-Size OTC Drug Packages
1999P-1340 Declared Eternity eau de Parfum Misbranded
1999P-2077 Reg/Guide to Label Medical Devices contain'g Phthalate Plast
1999P-2775 Refuse abbreviated new drug application for gabapentin tablt
1999P-4871 ANDA for Sterile Cefuroxime Sodium, USP
2000P-0653 Amend the product insert &/or label for Anthrax Vaccive adso
2000P-1468 ANDA for Sertraline Hydrochloride Capsules 25mg, 50mg & 100m
2000P-1550 Approve ANDA for Cefuroxime Axetil Products
2000P-1568 ANDA Suitability Petition for Ursodiol Oral Suspension
2002P-0317 Recall Aspartame as a Neurotoxic Drug
2003N-0076 Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
2003N-0400 Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
2003N-0573 Draft Animal Cloning Risk Assessment
2005E-0259 Patent Extension Application for EMTRIVA (emtricitabine), U.S. Patent No. 5,914,331
2005H-0271 Civil Money Penalty: TMJ Implants, Inc.
2005N-0279 Food Labeling; Gluten-Free Labeling of Foods
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
2006E-0034 Patent Extension Application for PREVICOX (firocoxib), U. S. Patent No. 5,981,576
2006E-0046 Patent Extension Application for Onyx Liquid Embolic System (LES), U.S. Patent No. 5,667,767
2006E-0240 Patent Extension Application for REVLIMID (lenalidomide), U.S. Patent No. 5,635,517
2006E-0478 Patent Extension Application for NovoLog insulin aspart (rDNA origin) injection, U.S. Patent No. 5,618,913
2006N-0062 Expanded Access to Investigational Drugs for Treatment Use
2006N-0528 Agency Information Collection Activities; Proposed Collection; Comment Request; Infant Formula Requirements
2006P-0255 discontinued formulation of Warner Chilcott's Duricel (cefadroxil) tablets 1 g was not discontinued for safety and efficacy reasons
2006P-0300 ANDA Suitability for Glycoprrolate Tablets, USP 1.5 mg
2006P-0394 Revise the labeling requirements for eggs sold in the United States
2006P-0498 Use of symbols on the principal display panel that would communicate to consumers the healthfulness of foods
2007D-0020 Medical Devices: Class II Special Controls Guidance Document: Oxygen Pressure Regulators and Oxygen Conserving Devices
2007D-0027 Voluntary Self Inspection of Medicated Feed Manufacturing Facilities
2007N-0016 Sentinel Network To Promote Medical Product Safety
2007P-0085 Adopt Regulations of General Applicability to all Food Standards that would Permit Deviations from the Requirements of the Individual Food Standards of Identity
2007P-0097 Issue a new regulation wine product the composition of wine , water, sugar, with or without flavorings and an alcohol content of less than 75% can not be marketed or sold with a wine varietal designa
2007P-0113 ANDA Suitability for 15% Amino Acid Injection Product
1998N-0337C Definition and Option of Alternative Labeling Requirements for Convenience-Size OTC Drug Packages
EREG 1 Consumer Healthcare Products Association Vol #: 1
1999P-1340 Declared Eternity eau de Parfum Misbranded
EMC 675 L. Colquhoun Vol #: 24
1999P-2077 Reg/Guide to Label Medical Devices contain'g Phthalate Plast
RET 1 88-07-0027 Box 1 Vol #: 3
1999P-2775 Refuse abbreviated new drug application for gabapentin tablt
RET 1 88-07-0027 Box 1 Vol #: 1
1999P-4871 ANDA for Sterile Cefuroxime Sodium, USP
RET 1 88-07-0027 Box 1 Vol #: 1
2000P-0653 Amend the product insert &/or label for Anthrax Vaccive adso
RET 1 88-07-0027 Box 1 Vol #: 1
2000P-1468 ANDA for Sertraline Hydrochloride Capsules 25mg, 50mg & 100m
RET 1 88-07-0027 Box 1 Vol #: 1
2000P-1550 Approve ANDA for Cefuroxime Axetil Products
RET 1 88-07-0027 Box 1 Vol #: 2
2000P-1568 ANDA Suitability Petition for Ursodiol Oral Suspension
RET 1 88-07-0027 Box 2 Vol #: 1
2002P-0317 Recall Aspartame as a Neurotoxic Drug
EMC 784 Mission Possible International Vol #: 10
EMC 785 Mission Possible International Vol #: 10
2003N-0076 Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
EMC 1464 J. Agro Vol #: 12
2003N-0400 Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
EREG 5 American Veterinary Medical Association Vol #: 15
EREG 6 American Veterinary Medical Association Vol #: 15
EREG 7 Council of State and Territorial Epidemiologists Vol #: 15
2003N-0573 Draft Animal Cloning Risk Assessment
C 442 D. Parris Vol #: 41
C 443 S. Shankle Vol #: 41
C 444 M. Johanns Vol #: 41
C 445 T. Siegrist Vol #: 41
EC 3801 Ms. Natz Sherwin Vol #: 22
EC 3802 Miss. Elizabeth Lopez Vol #: 22
EC 3803 Mrs. Debra Clinton Vol #: 22
EC 3804 Ms. Maureen Edwards Vol #: 22
EC 3805 Miss. Lisa Liu Vol #: 22
EC 3806 Dr. Tracy Ouellette Vol #: 22
EC 3807 Mr. John Fenker Vol #: 22
EC 3808 Miss. Lisa Rae Vol #: 22
EC 3809 Miss. Cindy Griffith Vol #: 22
EC 3810 Mrs. Tami Johnson Vol #: 22
EC 3811 Ms. debbie borgono Vol #: 22
EC 3812 Dr. Eugene B. Hanlon Vol #: 22
EC 3813 Miss. Laura Holmes Vol #: 22
EC 3814 Dr. Lisa Johnston Vol #: 22
EC 3815 Mr. Joseph Sapere Vol #: 22
EC 3816 Mr. Eric Thompson Vol #: 22
EC 3817 WSPCA Vol #: 22
EC 3818 Mrs. Donna Selquist Vol #: 22
EC 3819 Mr. Walter Lee IV Vol #: 22
EC 3820 Dr. Ellen Pill Vol #: 22
EC 3821 Mrs. Suzanne Jenuleson Vol #: 22
EC 3822 Ms. Pam Carey Vol #: 22
EC 3823 Mr. John Teevan Vol #: 22
EC 3824 Fundacin Altarriba Vol #: 22
EC 3825 Ms. Kristina Wetzel Vol #: 22
EC 3826 Dr. Krista Luck Vol #: 22
EC 3827 Ms. Monica Willett Vol #: 22
EC 3828 Miss. Kirsten Bracht Vol #: 22
EC 3829 Mrs. Jasey Carrick Vol #: 22
EC 3830 Mrs. jamie kordack Vol #: 22
EC 3831 Institute for Advanced Study Vol #: 22
EC 3832 Miss. Adrienne Dollyhigh Vol #: 22
EC 3833 Mrs. Nikola Garvey Vol #: 22
EC 3834 Miss. kristen chapman Vol #: 22
EC 3835 Miss. Kate Cushen Vol #: 22
EC 3836 Ms. Carole Smudin Vol #: 22
EC 3837 Ms. Deanne O'Donnell Vol #: 22
EC 3838 Miss. Emanuel van der Wiel Vol #: 22
EC 3839 Ms. Karen Ryder Vol #: 22
EC 3840 Mrs. Mikiko Takagi Vol #: 22
EC 3841 Ms. Laura Schatzkin Vol #: 22
EC 3842 Mrs. Mikiko Takagi Vol #: 22
EC 3843 Ms. jo gabriel Vol #: 22
EC 3844 Ms. Lacey Levitt Vol #: 22
EC 3845 Ms. Erika Villani Vol #: 22
EC 3846 Miss. katie sinclair Vol #: 22
EC 3847 Ms. J. Ackerman Vol #: 22
EC 3848 Ms. Harriet Bryan Vol #: 22
EC 3849 Mrs. Moselle Irr Vol #: 22
EC 3850 Miss. Stacie West Vol #: 22
EC 3851 Ms. Heather Rogers Vol #: 22
EC 3852 Mr. Ryan Smith Vol #: 22
EC 3853 Mr. Roberto de Moraes Vol #: 22
EC 3854 Miss. Elissar Khalek Vol #: 22
EC 3855 Mr. Patrick Morin Vol #: 22
EC 3856 Miss. Sarah Pruitt Vol #: 22
EC 3857 The National Humane Education Society (NHES) Vol #: 22
EC 3858 Center for Corporate Citizenship, Boston College Vol #: 22
EC 3859 Ms. Greta Ratliff Vol #: 22
EC 3860 Mrs. Kelle Bruckman Vol #: 22
EC 3861 Individual Vol #: 22
EC 3862 Los Alamos National Laboratory Vol #: 22
EC 3863 Mr. Rodney ANderson Vol #: 22
EC 3864 Ms. Heather Schmaedeke Vol #: 22
EC 3865 Sonoma people For ANIMAL Rights Vol #: 22
EC 3866 Ms. Elizabeth Mostov Vol #: 22
EC 3867 Ms. Ellen NeSmith Vol #: 22
EC 3868 Mr. Ravi Grover Vol #: 22
EC 3869 Ms. Catherine Anderson Vol #: 22
EC 3870 Mrs. Rebecca Roberts Vol #: 22
EC 3871 Ms. Felicia Watkins Vol #: 22
EC 3872 Mrs. Karen Fedorov Vol #: 22
EC 3873 Miss. Thandi Felix Vol #: 22
EC 3874 Ms. Karen Magee Vol #: 22
EC 3875 Ms. J Hutchinson Vol #: 22
EC 3876 Ms. Deanka Grisham Vol #: 22
EC 3877 Mrs. Christa Boroskin Vol #: 22
EC 3878 Mrs. Judy Ferraiolo Vol #: 22
EC 3879 Mr. Matthew Herrin Vol #: 22
EC 3880 Ms. Claudia Campeanu Vol #: 22
EC 3881 Mr. Ricky Atkins Vol #: 22
EC 3882 Mrs. Kathy Johnson Vol #: 22
EC 3883 Ms. Alexis Martin Vol #: 22
EC 3884 Mrs. Laura Rowles Vol #: 22
EC 3885 Miss. Alexandra Teixeira Vol #: 22
EC 3886 Mr. yati sivam Vol #: 22
EC 3887 Ms. Amanda Graham Vol #: 22
EC 3888 Mr. David Nielsen Vol #: 22
EC 3889 Mrs. Lisa Merrell Vol #: 22
EC 3890 Ms. Tanya Marie Cope Vol #: 22
EC 3891 Mrs. Aracelis Jaffe Vol #: 22
EC 3892 Ms. ENA SILVA VILLACORTA Vol #: 22
2005E-0259 Patent Extension Application for EMTRIVA (emtricitabine), U.S. Patent No. 5,914,331
N 1 FDA Vol #: 1
2005H-0271 Civil Money Penalty: TMJ Implants, Inc.
CS 22 FDA/DDM Vol #: 240
CS 23 FDA/DDM Vol #: 240
LET 7 Administrative Law Judge Vol #: 240
MO 23 TMJ Implants, Inc, and Robert W. Christensen, and Maureen K Mooney Vol #: 240
OR 22 Administrative Law Judge Vol #: 240
RC 1 FDA/CDRH to TMJ Implants, Inc., Dr. Robert W. Christensen, and Maureen K Mooeney Vol #: 240
2005N-0279 Food Labeling; Gluten-Free Labeling of Foods
EC 1860 Mr. Chester Burgess Vol #: 31
EC 1861 Ms. Ashley Enderlin Vol #: 31
EC 1862 Mr. Brian Fragassi Vol #: 31
EREG 51 A. Gatch Vol #: 32
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
C 18278 A. Jacobi Vol #: 198
2006E-0034 Patent Extension Application for PREVICOX (firocoxib), U. S. Patent No. 5,981,576
N 1 FDA Vol #: 1
2006E-0046 Patent Extension Application for Onyx Liquid Embolic System (LES), U.S. Patent No. 5,667,767
N 1 FDA Vol #: 1
2006E-0240 Patent Extension Application for REVLIMID (lenalidomide), U.S. Patent No. 5,635,517
N 1 FDA Vol #: 1
2006E-0478 Patent Extension Application for NovoLog insulin aspart (rDNA origin) injection, U.S. Patent No. 5,618,913
N 1 FDA Vol #: 1
2006N-0062 Expanded Access to Investigational Drugs for Treatment Use
C 24 Pendergast Consulting Vol #: 1
EMC 1 B. Yarczower MD Vol #: 1
2006N-0528 Agency Information Collection Activities; Proposed Collection; Comment Request; Infant Formula Requirements
N 2 FDA Vol #: 1
2006P-0255 discontinued formulation of Warner Chilcott's Duricel (cefadroxil) tablets 1 g was not discontinued for safety and efficacy reasons
N 1 FDA Vol #: 1
2006P-0300 ANDA Suitability for Glycoprrolate Tablets, USP 1.5 mg
PAV 1 FDA/CDER to Lachman Consultant Services Inc Vol #: 1
2006P-0394 Revise the labeling requirements for eggs sold in the United States
C 74 A. Fritz Vol #: 7
C 75 R. A. Christopher Vol #: 7
C 76 J. Kramer Vol #: 7
2006P-0498 Use of symbols on the principal display panel that would communicate to consumers the healthfulness of foods
C 82 M Grace Vol #: 1
C 83 Plumas Rural Services WIC - Women, Infants, & Children Vol #: 1
C 84 R Ditta Vol #: 1
C 85 C Newman Vol #: 1
C 86 D Nuss Vol #: 1
C 87 C Travers Vol #: 1
C 88 J Palmer Vol #: 1
2007D-0020 Medical Devices: Class II Special Controls Guidance Document: Oxygen Pressure Regulators and Oxygen Conserving Devices
EXT 1 Number not used Vol #: 1
2007D-0027 Voluntary Self Inspection of Medicated Feed Manufacturing Facilities
EXT 1 American Feed Industry Association Vol #: 1
2007N-0016 Sentinel Network To Promote Medical Product Safety
TR 1 Transcript of the March 7, 2007 meeting Vol #: 4
TR 2 Transcript of the March 8, 2007 meeting Vol #: 5
TS 12 GlaxoSmithKline Vol #: 3
TS 13 Cerner Corporation, Cerner Galt Division Vol #: 3
TS 14 Stephen A Goldman Consulting Services LLC Vol #: 3
TS 15 GE Healthcare, Practice Solutions Vol #: 3
TS 16 Johnson & Johnson Vol #: 3
TS 17 AAFP National Research Network Vol #: 3
TS 18 Applied Clinical Intelligence LLC, American Pharmacist Association Collaboration Vol #: 3
TS 19 Community MTM Services Inc Vol #: 3
TS 20 Quintiles Inc Vol #: 3
TS 21 Exponent Inc Vol #: 3
TS 22 CDISC Vol #: 3
TS 23 Pfizer Vol #: 3
TS 24 Novlis Vol #: 3
TS 25 ProSanos Corporation Vol #: 3
TS 26 ECRI Vol #: 3
TS 27 Northrop Grumman Vol #: 3
TS 28 Sermo In Vol #: 3
2007P-0085 Adopt Regulations of General Applicability to all Food Standards that would Permit Deviations from the Requirements of the Individual Food Standards of Identity
C 1 National Confectioners Association Vol #: 2
2007P-0097 Issue a new regulation wine product the composition of wine , water, sugar, with or without flavorings and an alcohol content of less than 75% can not be marketed or sold with a wine varietal designa
LET 1 Arbor Hill Grapery Vol #: 1
2007P-0113 ANDA Suitability for 15% Amino Acid Injection Product
ACK 1 FDA / DDM to B Braun Medical, Inc. Vol #: 1
CP 1 B Braun Medical, Inc. Vol #: 1

Page created on March 26, 2007 ue

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