| | | | | | | | | | |
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| Dockets Entered
On February 8, 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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| |
|
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| |
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| |
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| 2003N-0573
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| Draft Animal Cloning Risk Assessment
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| |
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| 2005D-0091
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| Guidance for Industry on Waiver of User Fees for Fixed Dose Combination Products and Co-Packaged Products to Treat HIV
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| |
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| 2005N-0279
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| Food Labeling; Gluten-Free Labeling of Foods
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| |
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| 2005N-0373
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| Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants
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| |
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| 2005N-0403
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| Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs
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| |
|
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| 2006A-0318
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| Request for Advisory Opinion Concerning Orange Book Listing of Patents
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| |
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| 2006D-0383
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| Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases
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| |
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|
| 2006E-0500
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| Patent Extension Application for Azilect (rasagiline mesylate), U.S. Patent No. 5,453,446
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| |
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|
| 2006E-0501
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| Patent Extension Application for Gardasil (Quadravalent Human Papillomavirus Recombinant Vaccine), U.S. Patent No. 5,820,870
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| |
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|
| 2006E-0502
|
| Patent Extension Application for Prezista (darunavir ethanolate), U.S. Patent No. 6,248,775
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| |
|
|
| 2006E-0532
|
| Patent Extension Application for Anthelios SX Daily Moisturizing Cream With Sunscreen, U.S. Patent No. 4,585,597
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| |
|
|
| 2006N-0036
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Possible Footnotes and Cueing Schemes to Help Consumers Interpret Quantitative Trans Fat Disclosur
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|
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|
|
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|
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| 2006P-0069
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| Health Claim Petition: Soluble Fiber from Certain Foods and Coronary Heart Disease
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| |
|
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| 2006P-0094
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| To undertake rulemaking to establish specific rules and regulations governing the definition of natural before a natural claim can be made on foods and beverages regulated by the FDA
|
| |
|
|
| 2006P-0154
|
| remove from the market, the prescription version of Xenical (orlistat,Roche Pharmaceuticals)
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| |
|
|
| 2006P-0272
|
| ANDA Suitability for 0.9% Sodium Chloride Injection
|
| |
|
|
| 2006P-0306
|
| Publish specific requirements for applications seeking approval to market therapeutically equivalent versions of insulin and human growth hormone
|
| |
|
|
| 2006P-0307
|
| To amend 21CFR 201.17 regarding expiration dates
|
| |
|
|
| 2006P-0309
|
| ANDA for ELOXATIN (oxaliplatin for injection) lyophilized powder for infusion, 50 mg and 100 mg vials
|
| |
|
|
| 2006P-0310
|
| Compel the Agency to follow requirements of the Drug Listing Act of 1972
|
| |
|
|
| 2006P-0311
|
| Investigate and take regulatory action to protect surgical patients from a potential significant safety risk in connection with Propofol Injectable Emulsion marketed by Bedford Laboratories
|
| |
|
|
| 2006P-0450
|
| Revoke approval of Allergan's supplemental NDA #21-257/S-013 for Lumigan (bimatoprost ophthalmic solution 0.03%) and deny Alcon's supplemental NDA for Travatan (travopr
|
| |
|
|
| 2007E-0002
|
| Patent Extension Application for ELAPRASE (idursulfase), U.S. Patent No. 5,932,211
|
| |
|
|
| 2007E-0009
|
| Patent Extension Application for Myozyme (Aglucosidase alfa), U.S. Patent No. 6,118,045
|
| |
|
|
| 2007N-0016
|
| Sentinel Network To Promote Medical Product Safety
|
| |
|
|
| 2007P-0047
|
| Amend the Dosage of Oral Phenylephrine Listed in the Final Monogrph on Oral Decongestants
|
| |
|
|
| 2007V-0048
|
| Laser Light Show
|
|
| |
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
| |
|
|
| LET 18406
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18407
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18408
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18409
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 168
|
|
| | | | | | | |
|
| |
|
| LET 18410
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18411
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18412
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18413
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18414
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18415
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18416
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18417
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18418
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18419
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18420
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18421
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18422
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18423
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18424
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18425
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18426
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18427
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18428
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18429
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18430
|
| CPharmax, Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18431
|
| CPharmax, Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18432
|
| JOL Management
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18433
|
| Herbalife International of America INC
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18434
|
| Barmensen Labs, LLC
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18435
|
| Barmensen Labs, LLC
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18436
|
| Barmensen Labs, LLC
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18437
|
| Novartis Nutrition Corporation
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18438
|
| Nature's Way Products, Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18439
|
| Nature's Way Products, Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18440
|
| Garden of Life, Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18441
|
| Garden of Life, Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18442
|
| Garden of Life, Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18443
|
| Garden of Life, Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18444
|
| Garden of Life, Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18445
|
| Garden of Life, Inc.
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18446
|
| Pharmavite LLC
|
| Vol #:
|
| 168
|
|
| | | | | | | | |
|
| |
|
| LET 18447
|
| Beulah Land Corporation
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18448
|
| Harmonic Innerprizes
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18449
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18450
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18451
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18452
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18453
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18454
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18455
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18456
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18457
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18458
|
| Valeant Pharmaceuticals International
|
| Vol #:
|
| 168
|
| |
|
|
| LET 18459
|
| The Origin Foods SDN BHD
|
| Vol #:
|
| 168
|
| |
|
|
| 1999P-1340
|
| Declared Eternity eau de Parfum Misbranded
|
| |
|
|
| EMC 669
|
| J. Neal
|
| Vol #:
|
| 24
|
| |
|
|
| 2002P-0317
|
| Recall Aspartame as a Neurotoxic Drug
|
| |
|
|
| EMC 759
|
| J. Bowen
|
| Vol #:
|
| 10
|
| |
|
|
| EMC 760
|
| Mission Possible International
|
| Vol #:
|
| 10
|
| |
|
|
| EMC 761
|
| Mission Possible International
|
| Vol #:
|
| 10
|
| |
|
|
| EMC 762
|
| Mission Possible International
|
| Vol #:
|
| 10
|
|
| |
|
| 2003N-0573
|
| Draft Animal Cloning Risk Assessment
|
| |
|
|
| EMC 106
|
| A. Rademacher
|
| Vol #:
|
| 5
|
| |
|
|
| 2005D-0091
|
| Guidance for Industry on Waiver of User Fees for Fixed Dose Combination Products and Co-Packaged Products to Treat HIV
|
| |
|
|
| GDL 2
|
| Guidance
|
| Vol #:
|
| 1
|
| |
|
|
| NAD 2
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2005N-0279
|
| Food Labeling; Gluten-Free Labeling of Foods
|
| |
|
|
| EMC 309
|
| P. Faison
|
| Vol #:
|
| 32
|
| |
|
|
| EMC 310
|
| A. Cox
|
| Vol #:
|
| 32
|
| |
|
|
| EREG 36
|
| D. Patterson
|
| Vol #:
|
| 32
|
| |
|
|
| EREG 37
|
| Celiac
|
| Vol #:
|
| 32
|
| |
|
|
| EREG 38
|
| S. Dennis
|
| Vol #:
|
| 32
|
| |
|
|
| EREG 39
|
| K. Zorica
|
| Vol #:
|
| 32
|
| |
|
|
| EREG 40
|
| K. Hauser
|
| Vol #:
|
| 32
|
|
| | | | | | | | |
|
| |
|
| 2005N-0373
|
| Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants
|
| |
|
|
| EREG 3
|
| J. Kelley
|
| Vol #:
|
| 7
|
| |
|
|
| 2005N-0403
|
| Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs
|
|
|
|
|
|
|
| |
|
|
| C 85
|
| Tech Air
|
| Vol #:
|
| 9
|
| |
|
|
| C 86
|
| Scott-Gross Company Inc
|
| Vol #:
|
| 9
|
| |
|
|
| C 87
|
| Pharmaceutical Technologies Services, Cardinal Health
|
| Vol #:
|
| 9
|
| |
|
|
| C 88
|
| Indiana Oxygen Company
|
| Vol #:
|
| 9
|
| |
|
|
| C 89
|
| Bristol-Myers Squibb Company
|
| Vol #:
|
| 9
|
| |
|
|
| C 90
|
| Buchanan Ingersoll & Rooney PC
|
| Vol #:
|
| 9
|
| |
|
|
| C 91
|
| Four Courners Welding & Gas Supply
|
| Vol #:
|
| 9
|
| |
|
|
| EC 26
|
| NDC Working Group
|
| Vol #:
|
| 4
|
| |
|
|
| NEC 2
|
| FDA
|
| Vol #:
|
| 8
|
| |
|
|
| 2006A-0318
|
| Request for Advisory Opinion Concerning Orange Book Listing of Patents
|
| |
|
|
| LET 1
|
| FDA/CDER to Ropes & Gray LLP
|
| Vol #:
|
| 1
|
| |
|
|
| 2006D-0383
|
| Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases
|
|
|
|
|
|
|
| |
|
|
| AMD 1
|
| Lasersmith Light Show Systems, LLC
|
| Vol #:
|
| 1
|
| |
|
|
| 2006E-0500
|
| Patent Extension Application for Azilect (rasagiline mesylate), U.S. Patent No. 5,453,446
|
| |
|
|
| LET 2
|
| FDA/CDER to the U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2006E-0501
|
| Patent Extension Application for Gardasil (Quadravalent Human Papillomavirus Recombinant Vaccine), U.S. Patent No. 5,820,870
|
| |
|
|
| LET 2
|
| FDA/CDER to U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2006E-0502
|
| Patent Extension Application for Prezista (darunavir ethanolate), U.S. Patent No. 6,248,775
|
| |
|
|
| LET 2
|
| FDA/CDER to the U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
|
| |
|
| 2006E-0532
|
| Patent Extension Application for Anthelios SX Daily Moisturizing Cream With Sunscreen, U.S. Patent No. 4,585,597
|
| |
|
|
| LET 2
|
| FDA/CDER to the U.S. Patent and Trademark Office
|
| Vol #:
|
| 2
|
| |
|
|
| 2006N-0036
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Possible Footnotes and Cueing Schemes to Help Consumers Interpret Quantitative Trans Fat Disclosur
|
|
|
|
|
|
|
| |
|
|
| EMC 22
|
| J. Richards
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 23
|
| M.
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 24
|
| A. Tenholder
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 25
|
| H. Craig
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 26
|
| A. Veggie
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
| |
|
| EMC 27
|
| R. Withers
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 28
|
| D. Edwards
|
| Vol #:
|
| 1
|
|
| |
|
| 2006P-0069
|
| Health Claim Petition: Soluble Fiber from Certain Foods and Coronary Heart Disease
|
| |
|
|
| EMC 1
|
| B. Sachau
|
| Vol #:
|
| 2
|
| |
|
|
| 2006P-0094
|
| To undertake rulemaking to establish specific rules and regulations governing the definition of natural before a natural claim can be made on foods and beverages regulated by the FDA
|
|
|
|
|
|
|
| |
|
|
| C 5
|
| The Sugan Association
|
| Vol #:
|
| 2
|
| |
|
|
| 2006P-0154
|
| remove from the market, the prescription version of Xenical (orlistat,Roche Pharmaceuticals)
|
| |
|
|
| PDN 1
|
| FDA/CDER to Public Citizen Health Research Group, Case Western Reserve University
|
| Vol #:
|
| 1
|
|
| |
|
| 2006P-0272
|
| ANDA Suitability for 0.9% Sodium Chloride Injection
|
| |
|
|
| SUP 1
|
| Beckloff Associates
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0306
|
| Publish specific requirements for applications seeking approval to market therapeutically equivalent versions of insulin and human growth hormone
|
| |
|
|
| LET 1
|
| FDA/CDER to State of Vermont, State of Wisconsin, Statement of Minnesota, State of Kansas
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0307
|
| To amend 21CFR 201.17 regarding expiration dates
|
| |
|
|
| LET 2
|
| Royal Medical Group
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0309
|
| ANDA for ELOXATIN (oxaliplatin for injection) lyophilized powder for infusion, 50 mg and 100 mg vials
|
| |
|
|
| LET 1
|
| FDA/CDER to Frommer, Lawrence & Haug LLP
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0310
|
| Compel the Agency to follow requirements of the Drug Listing Act of 1972
|
| |
|
|
| LET 1
|
| FDA/CDER to Peiser & Associates Inc
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0311
|
| Investigate and take regulatory action to protect surgical patients from a potential significant safety risk in connection with Propofol Injectable Emulsion marketed by Bedford Laboratories
|
|
|
|
|
|
|
| |
|
|
| LET 1
|
| FDA/CDER to Foley & Lardner LLP
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0450
|
| Revoke approval of Allergan's supplemental NDA #21-257/S-013 for Lumigan (bimatoprost ophthalmic solution 0.03%) and deny Alcon's supplemental NDA for Travatan (travopr
|
| |
|
|
| C 2
|
| Alcon Inc
|
| Vol #:
|
| 2
|
| |
|
|
| 2007E-0002
|
| Patent Extension Application for ELAPRASE (idursulfase), U.S. Patent No. 5,932,211
|
| |
|
|
| LET 3
|
| FDA/CDER to the U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2007E-0009
|
| Patent Extension Application for Myozyme (Aglucosidase alfa), U.S. Patent No. 6,118,045
|
| |
|
|
| LET 2
|
| FDA/CDER to the U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2007N-0016
|
| Sentinel Network To Promote Medical Product Safety
|
|
| | | | | | | | |
|
| |
|
| EAPE 208
|
| Stephenson, Hugo
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 209
|
| Cheetham, Craig
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 210
|
| Jones, Judith
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 211
|
| Sholtes, Deborah
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 212
|
| Trontell, Anne
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 213
|
| Binzer, Margaret
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 214
|
| Nourjah, Parivash
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 215
|
| Smith, Scott
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 216
|
| Villarraga, Marta
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 217
|
| Randhawa, Gurvaneet
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 218
|
| Robinson, Jill E.
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 219
|
| Mason, Tanyss
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 220
|
| Handrigan, Michael
|
| Vol #:
|
| 1
|
| |
|
|
| 2007P-0047
|
| Amend the Dosage of Oral Phenylephrine Listed in the Final Monogrph on Oral Decongestants
|
| |
|
|
| ACK 1
|
| FDA/DDM to University of Florida
|
| Vol #:
|
| 1
|
| |
|
|
| CP 1
|
| University of Florida
|
| Vol #:
|
| 1
|
| |
|
|
| 2007V-0048
|
| Laser Light Show
|
| |
|
|
| ACK 1
|
| FDA /DDM to Baylor University
|
| Vol #:
|
| 1
|
| |
|
|
| VAR 1
|
| Baylor University
|
| Vol #:
|
| 1
|
|
|
