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| Dockets Entered
On March 22, 2007
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| Docket #
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| Title
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 2002P-0187
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| Exemption of any connector in lead having a conductive conne
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| 2002P-0189
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| Physical form of drug product in to a oral liquid generic
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| 2002P-0191
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| Request for immediate final approval of tramadol Hydrochlori
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| 2002P-0198
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| ANADA for ivermectin having a different dosage form (oral ge
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| 2002P-0207
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| SRNT petition to regulate SF Garrett's Nicotine Water
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| 2002P-0225
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| ANDA for Levorphanol Tartrate Tablets
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| 2002P-0241
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| Classification of Transscutaneous Air Conduction Hearing Aid
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| 2002P-0246
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| Pharmacies of hospitals/other health care entities
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| 2002P-0247
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| ANDA Suitability for Clozapine 50 mg Tablets
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| 2002P-0252
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| Seek immediate final approval of generic tramadol hydrochlor
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| 2002P-0270
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| Suitability Petition for Hydrocodone Bitartrate/Ibuprofen 5
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| 2002P-0285
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| Combination oxycodone hydrochloride/acetaminophen tablet
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| 2002P-0358
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| ANDA for amoxicillin tabs for oral suspension 300 & 600mg
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| 2002P-0360
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| Chemical Cleaning Products for Industrial Food
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| 2002P-0392
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| Determine Whether Ortho-Tri-Cyclen-21 has been Voluntarily
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| 2002P-0394
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| Make determination of ANDA suitability for Amiodarone Hydroc
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| 2002P-0395
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| Determine whether Ortho-Cyclen-21 Tablets,NDA 19 652 have
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| 2003N-0573
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| Draft Animal Cloning Risk Assessment
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| 2004P-0464
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| Vitamin D & Calcium & Reduced Risk of Osteoporosis
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| 2005N-0279
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| Food Labeling; Gluten-Free Labeling of Foods
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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| 2006N-0527
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Threshold of Regulation for Substances Used in Food-Contact Articles
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| 2006P-0267
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| ANDA Suitability for Dextroamphetamine Sulfate Tablets
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| 2007M-0038
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| Fujirebio Mesomark Assay
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| 2007N-0016
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| Sentinel Network To Promote Medical Product Safety
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| 2007N-0061
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| Sipuleucel-T Dendreon
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| 2007N-0092
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Food and Drug Administration Rapid Response Surveys
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| 2007P-0079
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| To sanction third party independent scientific analysis of zine gluconate (ZICAM) additional safety standards for the homeopathic industry
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| 2007P-0097
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| 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
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET 19594
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 174
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| LET 19595
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 174
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| LET 19596
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 174
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| LET 19597
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 174
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|
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| LET 19598
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 174
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| LET 19599
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 174
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| LET 19600
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 174
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| LET 19601
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 174
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| LET 19602
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 174
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|
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| LET 19603
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| Enzymatic Therapy, Inc.
|
| Vol #:
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| 174
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| |
|
|
| LET 19604
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 174
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| |
|
|
| LET 19605
|
| Enzymatic Therapy, Inc.
|
| Vol #:
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| 174
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| |
|
|
| LET 19606
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19607
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 174
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| |
|
|
| LET 19608
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19609
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19610
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19611
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19612
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19613
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19614
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19615
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19616
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19617
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19618
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19619
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19620
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19621
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19622
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19623
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 174
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| |
|
|
| LET 19624
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 174
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| |
|
|
| LET 19625
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 174
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| |
|
|
| LET 19626
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19627
|
| Doctor's Best, Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| 2002P-0187
|
| Exemption of any connector in lead having a conductive conne
|
| |
|
|
| RET 1
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| 88-07-0027 Box 4
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| Vol #:
|
| 1
|
| |
|
|
| 2002P-0189
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| Physical form of drug product in to a oral liquid generic
|
| |
|
|
| RET 1
|
| 88-07-0027 Box 4
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| Vol #:
|
| 1
|
| |
|
|
| 2002P-0191
|
| Request for immediate final approval of tramadol Hydrochlori
|
|
| | | | | | | | |
|
| |
|
| RET 1
|
| 88-07-0027 Box 4
|
| Vol #:
|
| 1
|
| |
|
|
| 2002P-0198
|
| ANADA for ivermectin having a different dosage form (oral ge
|
| |
|
|
| RET 1
|
| 88-07-0027 Box 4
|
| Vol #:
|
| 1
|
|
| |
|
| 2002P-0207
|
| SRNT petition to regulate SF Garrett's Nicotine Water
|
| |
|
|
| RET 1
|
| 88-07-0027 Box 4
|
| Vol #:
|
| 1
|
| |
|
|
| 2002P-0225
|
| ANDA for Levorphanol Tartrate Tablets
|
| |
|
|
| RET 1
|
| 88-07-0027 Box 4
|
| Vol #:
|
| 1
|
| |
|
|
| 2002P-0241
|
| Classification of Transscutaneous Air Conduction Hearing Aid
|
| |
|
|
| RET 1
|
| 88-07-0027 Box 4
|
| Vol #:
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| 1
|
| |
|
|
| 2002P-0246
|
| Pharmacies of hospitals/other health care entities
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| |
|
|
| RET 1
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| 88-07-0027 Box 4
|
| Vol #:
|
| 1
|
| |
|
|
| 2002P-0247
|
| ANDA Suitability for Clozapine 50 mg Tablets
|
| |
|
|
| RET 1
|
| 88-07-0027 Box 4
|
| Vol #:
|
| 1
|
| |
|
|
| 2002P-0252
|
| Seek immediate final approval of generic tramadol hydrochlor
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| |
|
|
| RET 1
|
| 88-07-0027 Box 4
|
| Vol #:
|
| 1
|
| |
|
|
| 2002P-0270
|
| Suitability Petition for Hydrocodone Bitartrate/Ibuprofen 5
|
| |
|
|
| RET 1
|
| 88-07-0027 Box 4
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| Vol #:
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| 1
|
|
| |
|
| 2002P-0285
|
| Combination oxycodone hydrochloride/acetaminophen tablet
|
| |
|
|
| RET 1
|
| 88-07-0027 Box 5
|
| Vol #:
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| 1
|
| |
|
|
| 2002P-0358
|
| ANDA for amoxicillin tabs for oral suspension 300 & 600mg
|
| |
|
|
| RET 1
|
| 88-07-0027 Box 5
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| Vol #:
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| 1
|
| |
|
|
| 2002P-0360
|
| Chemical Cleaning Products for Industrial Food
|
| |
|
|
| RET 1
|
| 88-07-0027 Box 5
|
| Vol #:
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| 1
|
| |
|
|
| 2002P-0392
|
| Determine Whether Ortho-Tri-Cyclen-21 has been Voluntarily
|
| |
|
|
| RET 1
|
| 88-07-0027 Box 5
|
| Vol #:
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| 1
|
| |
|
|
| 2002P-0394
|
| Make determination of ANDA suitability for Amiodarone Hydroc
|
| |
|
|
| RET 1
|
| 88-07-0027 Box 5
|
| Vol #:
|
| 1
|
| |
|
|
| 2002P-0395
|
| Determine whether Ortho-Cyclen-21 Tablets,NDA 19 652 have
|
|
| | | | | | | | |
|
| |
|
| RET 1
|
| 88-07-0027 Box 5
|
| Vol #:
|
| 1
|
| |
|
|
| 2003N-0573
|
| Draft Animal Cloning Risk Assessment
|
| |
|
|
| C 435
|
| T. Lee
|
| Vol #:
|
| 41
|
| |
|
|
| C 436
|
| L. Salerno
|
| Vol #:
|
| 41
|
| |
|
|
| C 437
|
| T. Chaillet
|
| Vol #:
|
| 41
|
| |
|
|
| C 438
|
| E. Van Horn
|
| Vol #:
|
| 41
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| |
|
|
| C 439
|
| M. Verity
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| Vol #:
|
| 41
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| |
|
|
| C 440
|
| R. Capozzelli
|
| Vol #:
|
| 41
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| |
|
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| C 441
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| S. Berry-Foxx
|
| Vol #:
|
| 41
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| |
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|
| EC 3722
|
| Ms. sheila lewis
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| Vol #:
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| 21
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|
| EC 3723
|
| Ms. Deanna Nihill
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| Vol #:
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| 21
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| |
|
|
| EC 3724
|
| Mrs. Tracey Goldie
|
| Vol #:
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| 21
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| |
|
|
| EC 3725
|
| Ms. Bernice McShane
|
| Vol #:
|
| 21
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| |
|
|
| EC 3726
|
| Ms. Marc Hoeksema
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| Vol #:
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| 21
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| |
|
|
| EC 3727
|
| Mr. Justin Case
|
| Vol #:
|
| 21
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| |
|
|
| EC 3728
|
| Ms. Cynthia Hever
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| Vol #:
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| 21
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| |
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| EC 3729
|
| Ms. Christina Tauber
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| Vol #:
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| 21
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| |
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|
| EC 3730
|
| Mrs. Angela Petruncio
|
| Vol #:
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| 21
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| |
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| EC 3731
|
| Ms. sauwah tsang
|
| Vol #:
|
| 21
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| |
|
|
| EC 3732
|
| Mrs. Marie Babione
|
| Vol #:
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| 21
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| |
|
|
| EC 3733
|
| Ms. dorothy lynne davies
|
| Vol #:
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| 21
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|
| EC 3734
|
| Mrs. Lena Sullivan
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| Vol #:
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| 21
|
| |
|
|
| EC 3735
|
| WSPCA
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3736
|
| Ms. Leslie Jones
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3737
|
| Miss. mateja juras
|
| Vol #:
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| 21
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| |
|
|
| EC 3738
|
| Mrs. JENNIFER BYERLY
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3739
|
| Ms. Donna Juselis
|
| Vol #:
|
| 21
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| |
|
|
| EC 3740
|
| Mrs. Gigi Green
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3741
|
| Ms. robin jess
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3742
|
| Mrs. Diane Rencher
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3743
|
| Ms. Judy Pizarro
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3744
|
| WSPA
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3745
|
| Mr. Mark Sanders
|
| Vol #:
|
| 21
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| |
|
|
| EC 3746
|
| Ms. Corina Wylie
|
| Vol #:
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| 21
|
| |
|
|
| EC 3747
|
| University of Toronto [retired]
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3748
|
| None
|
| Vol #:
|
| 21
|
|
| | | | | | | |
|
| |
|
| EC 3749
|
| Ms. Constance Harvey
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3750
|
| Mrs. Tracy Maguire
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3751
|
| Ms. Lynda Nesbitt
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3752
|
| Miss. Jen S
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| Vol #:
|
| 21
|
| |
|
|
| EC 3753
|
| Mr. Richard Wilhelm
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3754
|
| Mr. Henry Rosenfeld
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3755
|
| Ms. Christy Levine
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3756
|
| Mr. Timothy McDonald
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3757
|
| Ms. Lisa Marshall
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3758
|
| Mrs. Shayna Gardiner
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3759
|
| Ms. roberta claypool
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3760
|
| Mrs. Gwen Hartwell
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3761
|
| Mr. Charles Hernandez
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3762
|
| Ms. Amy Schumacher
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3763
|
| Miss. victoria wong
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3764
|
| Mrs. Laura de la Garza
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3765
|
| Miss. Viviana Gunter
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3766
|
| Ms. Frances Caldwell
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3767
|
| Miss. marbella brown
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3768
|
| Mrs. Tereza Mulligan
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3769
|
| Dr. Stacey Schaefer
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3770
|
| Ms. Pamela Kjono
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3771
|
| Ms. Callie Jordan
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3772
|
| Ms. Peppi Boudreau
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3773
|
| Ms. Claudia McConnell
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3774
|
| Mr. Lawrence Toush
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3775
|
| Ms. Esther Meima
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3776
|
| Ms. Mai Hermann
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3777
|
| Ms. Patricia De Lorenzi
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3778
|
| Dr. Brenda Bailey
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3779
|
| N/A
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3780
|
| Dr. Connie Boczarski
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3781
|
| Mrs. Judit Toth
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3782
|
| Ms. Marilyn Wilson
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3783
|
| Ms. Molly Love
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3784
|
| Mr. Matt DeLuca
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3785
|
| Ms. Lisa Parda
|
| Vol #:
|
| 21
|
|
| | | | | | | | |
|
| |
|
| EC 3786
|
| Ms. Patricia Vargas
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3787
|
| Mr. Mark Langley
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3788
|
| Mrs. Andrea Khunnadchian
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3789
|
| Ms. Cecilia Ryan
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3790
|
| Ms. Dorota Miller
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3791
|
| Ms. CAROL Collins
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3792
|
| Ms. M Warminski
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3793
|
| Ms. Janee Trotman
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3794
|
| Dr. haleh kashani
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3795
|
| Ms. Michele Napiorski
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3796
|
| Ms. Mary Gutzwiller
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3797
|
| Mrs. Sally Cauthen
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3798
|
| Mrs. TerryAnn Towers
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3799
|
| Ms. Mikki Chalker
|
| Vol #:
|
| 21
|
| |
|
|
| EC 3800
|
| Ms. Celeste Oehl
|
| Vol #:
|
| 21
|
| |
|
|
| 2004P-0464
|
| Vitamin D & Calcium & Reduced Risk of Osteoporosis
|
| |
|
|
| C 5
|
| Tufts University
|
| Vol #:
|
| 9
|
| |
|
|
| C 6
|
| Grocery Manufacturers/Food Products Association (GMA/FPA)
|
| Vol #:
|
| 9
|
| |
|
|
| C 7
|
| Autoimmunity Research Foundation
|
| Vol #:
|
| 9
|
| |
|
|
| C 8
|
| National Osteoporosis Foundation
|
| Vol #:
|
| 9
|
| |
|
|
| 2005N-0279
|
| Food Labeling; Gluten-Free Labeling of Foods
|
| |
|
|
| C 697
|
| J Gee
|
| Vol #:
|
| 32
|
| |
|
|
| C 698
|
| J Petty
|
| Vol #:
|
| 32
|
| |
|
|
| EC 1858
|
| Mr. Laurence Harris
|
| Vol #:
|
| 31
|
| |
|
|
| EC 1859
|
| Mrs. tyra smith
|
| Vol #:
|
| 31
|
| |
|
|
| 2005P-0411
|
| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
|
| |
|
|
| C 18276
|
| K. Langley
|
| Vol #:
|
| 198
|
| |
|
|
| 2006N-0527
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Threshold of Regulation for Substances Used in Food-Contact Articles
|
| |
|
|
| N 2
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0267
|
| ANDA Suitability for Dextroamphetamine Sulfate Tablets
|
| |
|
|
| PAV 1
|
| FDA/CDER to Lachman Consultant Services Inc
|
| Vol #:
|
| 1
|
| |
|
|
| 2007M-0038
|
| Fujirebio Mesomark Assay
|
| |
|
|
| AAV 1
|
| Fujirebio Diagnostics, Inc.
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
| |
|
| 2007N-0016
|
| Sentinel Network To Promote Medical Product Safety
|
| |
|
|
| TS 8
|
| The LeapFrog Group
|
| Vol #:
|
| 2
|
| |
|
|
| TS 9
|
| Marshfield Clinic
|
| Vol #:
|
| 2
|
| |
|
|
| TS 10
|
| Kaiser Permanente
|
| Vol #:
|
| 2
|
| |
|
|
| TS 11
|
| Brigham and Women's Hospital and Harvard Medical School
|
| Vol #:
|
| 2
|
| |
|
|
| 2007N-0061
|
| Sipuleucel-T Dendreon
|
| |
|
|
| EC 102
|
| Mrs. Mansha Bulchandani
|
| Vol #:
|
| 1
|
| |
|
|
| EC 103
|
| geisinger
|
| Vol #:
|
| 1
|
| |
|
|
| EC 104
|
| Mrs. Betty Settle
|
| Vol #:
|
| 1
|
| |
|
|
| EC 105
|
| Mr. John Pearson
|
| Vol #:
|
| 1
|
| |
|
|
| 2007N-0092
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Food and Drug Administration Rapid Response Surveys
|
| |
|
|
| N 1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2007P-0079
|
| To sanction third party independent scientific analysis of zine gluconate (ZICAM) additional safety standards for the homeopathic industry
|
| |
|
|
| EC 1
|
| Ms. Dorene Smith
|
| Vol #:
|
| 1
|
|
| |
|
| 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
|
|
|
|
|
|
|
| |
|
|
| EC 1
|
| Mr. Michael La Vean
|
| Vol #:
|
| 1
|
|
|
