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Dockets Management

Dockets Entered On October 24, 2007
Docket # Title
1997E-0013 Reteplase; Patent Term Extension Application No. 5,223,256
2003E-0243 Patent Extension for InFuse Bone Graft/LT-Cage Lumbar Tapered Fusion Device, 5,984,967
2003E-0244 Patent InFuse Bone Graft/LT-CAGE Lumbar Tapered Fusion Device, 5,782,919
2003E-0252 Patent Extension for A180 (danofloxacin mesylate), 4,861,779
2003E-0256 Patent Extension for Ranexa (ranolazine), 4,567,264
2004D-0028 Draft Consumer Advisory regarding Advice for Subgroups of a Population regarding Mercury in Fish and Shellfish
2005E-0259 Patent Extension Application for EMTRIVA (emtricitabine), U.S. Patent No. 5,914,331
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-0354 Patent Extension Application for VAPRISOL (conivaptan hydrochloride), U.S. Patent No. 5,723,606
2006E-0478 Patent Extension Application for NovoLog insulin aspart (rDNA origin) injection, U.S. Patent No. 5,618,913
2006N-0133 Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Evaluation of Variations in Content and Format of the Brief Summary in Direct-to-Consumer (DTC) Print Adver
2006N-0454 Use of Ozone-Depleting Substances; Removal of Essential-Use Designations
2006P-0394 Revise the labeling requirements for eggs sold in the United States
2007D-0290 Guidance for Industry: Cell Selection Devices for Point of Care Production of Minimally Manipulated Autologous Peripheral Blood Stem Cells (PBSCs)
2007D-0401 Guidance for Industry, FDA, and Foreign Governments: FY 2008 Medical Device User Fee Small Business Qualification and Certification
2007N-0114 Electronic Distribution of Prescribing Information for Prescription Drug Products; Public Hearing
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-0262 Use of Ozone-Depleting Substances; Removal of Essential-Use Designation (Epinephrine)
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
2007P-0047 Amend the Dosage of Oral Phenylephrine Listed in the Final Monogrph on Oral Decongestants
2007P-0235 Change the labeling requirements for eggs sold in the United States
2007P-0320 Regulation or Guideline to Label Medical Devices that Leach DEHP Plasticizers
1997E-0013 Reteplase; Patent Term Extension Application No. 5,223,256
LET 5 FDA/CDER to the U.S. Patent and Trademark Office Vol #: 1
2003E-0243 Patent Extension for InFuse Bone Graft/LT-Cage Lumbar Tapered Fusion Device, 5,984,967
LET 5 FDA/CDER to the U.S. Patent and Trademark Office Vol #: 1
2003E-0244 Patent InFuse Bone Graft/LT-CAGE Lumbar Tapered Fusion Device, 5,782,919
LET 5 FDA/CDER to the U.S. Patent and Trademark Office Vol #: 1
2003E-0252 Patent Extension for A180 (danofloxacin mesylate), 4,861,779
LET 6 FDA/CDER to the U.S. Patent and Trademark Office Vol #: 1
2003E-0256 Patent Extension for Ranexa (ranolazine), 4,567,264
LET 9 FDA/CDER to the U.S. Patent and Trademark Office Vol #: 1
2004D-0028 Draft Consumer Advisory regarding Advice for Subgroups of a Population regarding Mercury in Fish and Shellfish
GDL 2 Guidance Vol #: 1
2005E-0259 Patent Extension Application for EMTRIVA (emtricitabine), U.S. Patent No. 5,914,331
LET 6 FDA/CDER to the U.S. Patent and Trademark Office Vol #: 1
2006E-0034 Patent Extension Application for PREVICOX (firocoxib), U. S. Patent No. 5,981,576
LET 6 FDA/CDER to the U.S. Patent and Trademark Office Vol #: 1
2006E-0046 Patent Extension Application for Onyx Liquid Embolic System (LES), U.S. Patent No. 5,667,767
LET 5 FDA/CDER to the U.S. Patent and Trademark Office Vol #: 1
2006E-0240 Patent Extension Application for REVLIMID (lenalidomide), U.S. Patent No. 5,635,517
LET 5 FDA/CDER to the U.S. Patent and Trademark Office Vol #: 1
2006E-0354 Patent Extension Application for VAPRISOL (conivaptan hydrochloride), U.S. Patent No. 5,723,606
LET 5 FDA/CDER to the U.S. Patent and Trademark Office Vol #: 1
2006E-0478 Patent Extension Application for NovoLog insulin aspart (rDNA origin) injection, U.S. Patent No. 5,618,913
LET 6 FDA/CDER to the U.S. Patent and Trademark Office Vol #: 1
2006N-0133 Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Evaluation of Variations in Content and Format of the Brief Summary in Direct-to- Consumer (DTC) Print Adver
NAL 1 FDA Vol #: 1
SS 1 Supporting Statement Vol #: 1
2006N-0454 Use of Ozone-Depleting Substances; Removal of Essential-Use Designations
C 4244 Number not used Vol #: 40
C 4245 Number not used Vol #: 40
2006P-0394 Revise the labeling requirements for eggs sold in the United States
C 435 D. Polastry Vol #: 7
C 436 D Robique Vol #: 7
C 437 R Robinson Vol #: 7
C 438 Unknown Vol #: 7
C 439 R Law Vol #: 7
C 440 Unknown Vol #: 7
C 441 M Warner Vol #: 7
C 442 R Collson Vol #: 7
C 443 J Shaffer Vol #: 7
C 444 J Katz Vol #: 7
C 445 Y Kita Vol #: 7
C 446 K Manuell Vol #: 7
C 447 D El Nahas Vol #: 7
C 448 M Schroeder Vol #: 7
C 449 M Kertess Vol #: 7
C 450 L Harris Vol #: 7
C 451 C Neyman Vol #: 7
C 452 H Blu Vol #: 7
C 453 C Kelemen Vol #: 7
C 454 A Adolph Vol #: 7
C 455 R Goodin Vol #: 7
C 456 A Byrne Vol #: 7
C 457 J Kaidjak Vol #: 7
C 458 T Angell Vol #: 7
C 459 L Horrigan Vol #: 7
C 460 A Parrish Vol #: 7
2007D-0290 Guidance for Industry: Cell Selection Devices for Point of Care Production of Minimally Manipulated Autologous Peripheral Blood Stem Cells (PBSCs)
C 1 Hyman, Phelps & McNamara (HPM) Vol #: 1
2007D-0401 Guidance for Industry, FDA, and Foreign Governments: FY 2008 Medical Device User Fee Small Business Qualification and Certification
GDL 1 Guidance Vol #: 1
NAD 1 FDA Vol #: 1
2007N-0114 Electronic Distribution of Prescribing Information for Prescription Drug Products; Public Hearing
N 1 FDA 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
EREG 3 A. Shao Vol #: 1
2007N-0262 Use of Ozone-Depleting Substances; Removal of Essential-Use Designation (Epinephrine)
C 3 The American Association for Respiratory Care (AARC) 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 5 The American Academy of Orthopaedic Surgeons (AAOS/Academy) Vol #: 1
2007N-0356 BEHIND THE COUNTER AVAILABILITY OF CERTAIN DRUGS; Public Meeting
EAPE 184 Mann Healthcare Ltd Vol #: 1
EAPE 185 Avalere Health LLC Vol #: 1
EC 25 Mr. Monte Thompson Vol #: 1
2007P-0047 Amend the Dosage of Oral Phenylephrine Listed in the Final Monogrph on Oral Decongestants
NM 1 FDA Vol #: 1
2007P-0235 Change the labeling requirements for eggs sold in the United States
C 209 E Ody Vol #: 2
C 210 Unknown Vol #: 2
C 211 R Robinson Vol #: 2
C 212 unknown Vol #: 2
C 213 R Law Vol #: 2
C 214 M Warner Vol #: 2
C 215 R Collson Vol #: 2
C 216 J Shaffer Vol #: 2
C 217 J Katz Vol #: 2
C 218 Y Kita Vol #: 2
C 219 K Manuell Vol #: 2
C 220 D El Nahas Vol #: 2
C 221 M Schroeder Vol #: 2
C 222 M Kertess Vol #: 2
C 223 L Harris Vol #: 2
C 224 C Neyman Vol #: 2
C 225 H Blu Vol #: 2
C 226 C Kelemen Vol #: 2
C 227 A Adolph Vol #: 2
C 228 R Goodin Vol #: 2
C 229 A Byrne Vol #: 2
C 230 J Kaidjak Vol #: 2
C 231 T Angell Vol #: 2
C 232 L Horrigan Vol #: 2
C 233 A Parrish Vol #: 2
2007P-0320 Regulation or Guideline to Label Medical Devices that Leach DEHP Plasticizers
EC 17 Mrs. Marina Yuan Vol #: 1

Page created on October 24, 2007 ue

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