| | | | | |
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| Dockets Entered
On March 23, 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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| 2000P-1668
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| Action against mfrs&dists of garlic supplements misbranded
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| |
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| 2000P-1687
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| Amend definition & standard of identity for parmesan cheese
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| |
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| 2001P-0061
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| Request to file an ANDA for Ifosfamide for Injection
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| |
|
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| 2001P-0117
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| Rescind Approval of Solid Oral Dosage form of Metaxalone
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| |
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| 2001P-0119
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| Reclass. Cyclosporine Diagnostic Test Devices from Class III
|
| |
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| 2001P-0122
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| To Remove False and Deceptive Labeling for Transderm Scop
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| |
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| 2001P-0130
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| Hydrocodone Bitartrate and Acetaminophen Products
|
| |
|
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| 2001P-0136
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| ANDA filed for Midazolam Injection (Preservative Free)
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| |
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| 2001P-0161
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| Magnification Devices
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| |
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| 2001P-0209
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| Prescription Drug Products list amendment&approve new dosage
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| |
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| 2001P-0235
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| Reclassification of Cyclosporine Immunoassay
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| |
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| 2001P-0250
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| Dissemination of Non-Misleading Information/Off-Label Uses
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| |
|
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| 2001P-0252
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| ANDA Suitability for Dextroamphetamine Sulfate Tablets 15 mg
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| |
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| 2001P-0268
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| Reformat label for prescription drug for asthma medication
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| |
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| 2001P-0283
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| ANDA for Pentoxifylline Extended-release Tablets, 500 mg.
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| |
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| 2001P-0288
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| ANDA Suitability Petition for Fluorouracil Topital Solution
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| |
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| 2001P-0291
|
| ANDA suitability for topical cream containing 5% lidocaine
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| |
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| 2001P-0302
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| Anda Suitability Petition for TestoCreme 5% (Testosterone)
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| |
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| 2001P-0315
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| Withdrawal of product from sale in the US
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| |
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| 2001P-0334
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| Revoke Invalid FDA Regulations
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| |
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| 2001P-0343
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| Metal/Metal Semi-Constrained Hip Joint Prosthesis
|
| |
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| 2002P-0026
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| ANDA for Paclitaxel, ANDA 75-184
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| |
|
|
| 2002P-0033
|
| Carbidopa & Levodopa Orally Disintegrating Tablets
|
| |
|
|
| 2002P-0043
|
| Determine Pipracil Was Withdrawn For Safety Reasons
|
| |
|
|
| 2002P-0059
|
| Refrain from Approving ANDA for Isotretinoin Drug Products
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| |
|
|
| 2002P-0078
|
| ANDA for Baclofen Orally Disintegrating Tablets, 10 mg & 20
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| |
|
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| 2002P-0084
|
| ANADA for a generic version of trimethoprim & sulfadiazine c
|
| |
|
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| 2002P-0105
|
| ANDA Suitability for Oxycodone and Acetaminophen Tablets
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| |
|
|
| 2002P-0127
|
| Determine if Phenergan has been withdrawn or withheld from s
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| |
|
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| 2002P-0141
|
| ANDA for 1.2 mg estropipate (1.2 mg sodium estrone sulfate)
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| |
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| 2002P-0148
|
| ANDA for Fenofibrate Tablets (Tricor)
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| |
|
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| 2002P-0161
|
| ANDA Suitability for Isotretinoin Capsules 30 mg
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| |
|
|
| 2002P-0170
|
| ANDAs relaying Permax as reference listed drug not be appove
|
| |
|
|
| 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
|
|
| | | | | | | | |
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| |
|
| 2003N-0400
|
| Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
|
| |
|
|
| 2003N-0573
|
| Draft Animal Cloning Risk Assessment
|
| |
|
|
| 2005N-0262
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| Submission of Chemistry, Manufacturing, and Controls Information in a New Drug Application Under the New Pharmaceutical Quality Assessment System; Notice of Pilot Program
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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-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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| 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-0187
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Survey of Health Care Professionals on the Food Safety and Nutrition Information that they Provide to Pregnant Women
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| 2006N-0352
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| Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
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| 2007D-0020
|
| Medical Devices: Class II Special Controls Guidance Document: Oxygen Pressure Regulators and Oxygen Conserving Devices
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| |
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| 2007N-0019
|
| Medical Devices; Anesthesiology Devices; Oxygen Pressure Regulators and Oxygen Conserving Devices
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| |
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| 2007P-0079
|
| To sanction third party independent scientific analysis of zine gluconate (ZICAM) additional safety standards for the homeopathic industry
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| |
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| 2007P-0110
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| To enforce pediatric exclusivity rights for amlodipine
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| |
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| 2007P-0111
|
| Stay approval of any and all supplements to Lotrel concerning amlodipine and pediatric exclusivity
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| |
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| 2007P-0112
|
| Stay the implementation of recommendations currently being provided by CDER staff to companies concerning conduct of clinical trials and proposed statistical analyses for the efficacy requirements of
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|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
| |
|
|
| LET 19628
|
| RBC Life Sciences
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19629
|
| Aboca USA, Inc.
|
| Vol #:
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| 174
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| |
|
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| LET 19630
|
| Aboca USA, Inc.
|
| Vol #:
|
| 174
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| |
|
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| LET 19631
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| Aboca USA, Inc.
|
| Vol #:
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| 174
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| |
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| LET 19632
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| Aboca USA, Inc.
|
| Vol #:
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| 174
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| |
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| LET 19633
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| Aboca USA, Inc.
|
| Vol #:
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| 174
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| |
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| LET 19634
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| World Nutrition, Inc.
|
| Vol #:
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| 174
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| |
|
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| LET 19635
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| Sunfood Nutrition
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| Vol #:
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| 174
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| |
|
|
| LET 19636
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| Sunfood Nutrition
|
| Vol #:
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| 174
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| |
|
|
| LET 19637
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| New Chapter, Inc.
|
| Vol #:
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| 174
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| |
|
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| LET 19638
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| Natural Organics, Inc.
|
| Vol #:
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| 174
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| |
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| LET 19639
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| Natural Organics, Inc.
|
| Vol #:
|
| 174
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| |
|
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| LET 19640
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| Natural Organics, Inc.
|
| Vol #:
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| 174
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| |
|
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| LET 19641
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| Natural Organics, Inc.
|
| Vol #:
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| 174
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| |
|
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| LET 19642
|
| Iwade Research Institute of Mycology Co. Ltd.
|
| Vol #:
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| 174
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| |
|
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| LET 19643
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| Earthrise Nutritionals, LLC
|
| Vol #:
|
| 174
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| |
|
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| LET 19644
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19645
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19646
|
| Enzymatic Therapy, Inc.
|
| Vol #:
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| 174
|
|
| | | | | | | | |
|
| |
|
| LET 19647
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19648
|
| Melaleuca, Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19649
|
| Melaleuca, Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19650
|
| Melaleuca, Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19651
|
| Melaleuca, Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19652
|
| Melaleuca, Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19653
|
| Melaleuca, Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19654
|
| Melaleuca, Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19655
|
| Melaleuca, Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19656
|
| Melaleuca, Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19657
|
| Melaleuca, Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19658
|
| Melaleuca, Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19659
|
| Melaleuca, Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19660
|
| Melaleuca, Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19661
|
| Melaleuca, Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19662
|
| Herb Pharm
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19663
|
| Herb Pharm
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19664
|
| Swanson Health Products
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19665
|
| Source Naturals
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19666
|
| Planetary Herbals
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19667
|
| Source Naturals
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19668
|
| Botanical Laboratories, Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19669
|
| Botanical Laboratories, Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19670
|
| Botanical Laboratories, Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19671
|
| Botanical Laboratories, Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19672
|
| Botanical Laboratories, Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19673
|
| NBTY Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19674
|
| NBTY Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| 1999P-1340
|
| Declared Eternity eau de Parfum Misbranded
|
| |
|
|
| EMC 674
|
| No Signature
|
| Vol #:
|
| 24
|
| |
|
|
| 2000P-1668
|
| Action against mfrs&dists of garlic supplements misbranded
|
| |
|
|
| RET 1
|
| 88-07-0027 Box 2
|
| Vol #:
|
| 1
|
| |
|
|
| 2000P-1687
|
| Amend definition & standard of identity for parmesan cheese
|
| |
|
|
| RET 1
|
| 88-07-0027 Box 2
|
| Vol #:
|
| 1
|
| |
|
|
| 2001P-0061
| Request to file an ANDA for Ifosfamide
for Injection |
| | | | | | | | |
|
| |
|
|
|
| RET 1
|
| 88-07-0027 Box 2
|
| Vol #:
|
| 1
|
| |
|
|
| 2001P-0117
|
| Rescind Approval of Solid Oral Dosage form of Metaxalone
|
| |
|
|
| RET 1
|
| 88-07-0027 Box 2
|
| Vol #:
|
| 1
|
|
| |
|
| 2001P-0119
|
| Reclass. Cyclosporine Diagnostic Test Devices from Class III
|
| |
|
|
| RET 1
|
| 88-07-0027 Box 2
|
| Vol #:
|
| 1
|
| |
|
|
| 2001P-0122
|
| To Remove False and Deceptive Labeling for Transderm Scop
|
| |
|
|
| RET 1
|
| 88-07-0027 Box 2
|
| Vol #:
|
| 1
|
| |
|
|
| 2001P-0130
|
| Hydrocodone Bitartrate and Acetaminophen Products
|
| |
|
|
| RET 1
|
| 88-07-0027 Box 2
|
| Vol #:
|
| 1
|
| |
|
|
| 2001P-0136
|
| ANDA filed for Midazolam Injection (Preservative Free)
|
| |
|
|
| RET 1
|
| 88-07-0027 Box 2
|
| Vol #:
|
| 1
|
| |
|
|
| 2001P-0161
|
| Magnification Devices
|
| |
|
|
| RET 1
|
| 88-07-0027 Box 2
|
| Vol #:
|
| 1
|
| |
|
|
| 2001P-0209
|
| Prescription Drug Products list amendment&approve new dosage
|
| |
|
|
| RET 1
|
| 88-07-0027 Box 2
|
| Vol #:
|
| 1
|
| |
|
|
| 2001P-0235
|
| Reclassification of Cyclosporine Immunoassay
|
| |
|
|
| RET 1
|
| 88-07-0027 Box 2
|
| Vol #:
|
| 2
|
|
| |
|
| 2001P-0250
|
| Dissemination of Non-Misleading Information/Off-Label Uses
|
| |
|
|
| RET 1
|
| 88-07-0027 Box 2
|
| Vol #:
|
| 2
|
| |
|
|
| 2001P-0252
|
| ANDA Suitability for Dextroamphetamine Sulfate Tablets 15 mg
|
| |
|
|
| RET 1
|
| 88-07-0027 Box 2
|
| Vol #:
|
| 1
|
| |
|
|
| 2001P-0268
|
| Reformat label for prescription drug for asthma medication
|
| |
|
|
| RET 1
|
| 88-07-0027 Box 2
|
| Vol #:
|
| 1
|
| |
|
|
| 2001P-0283
|
| ANDA for Pentoxifylline Extended-release Tablets, 500 mg.
|
| |
|
|
| RET 1
|
| 88-07-0027 Box 3
|
| Vol #:
|
| 1
|
| |
|
|
| 2001P-0288
|
| ANDA Suitability Petition for Fluorouracil Topital Solution
|
| |
|
|
| RET 1
|
| 88-07-0027 Box 3
|
| Vol #:
|
| 1
|
| |
|
|
| 2001P-0291
|
| ANDA suitability for topical cream containing 5% lidocaine
|
|
| | | | | | | | |
|
| |
|
| RET 1
|
| 88-07-0027 Box 3
|
| Vol #:
|
| 1
|
| |
|
|
| 2001P-0302
|
| Anda Suitability Petition for TestoCreme 5% (Testosterone)
|
| |
|
|
| RET 1
|
| 88-07-0027 Box 3
|
| Vol #:
|
| 1
|
|
| |
|
| 2001P-0315
|
| Withdrawal of product from sale in the US
|
| |
|
|
| RET 1
|
| 88-07-0027 Box 3
|
| Vol #:
|
| 1
|
| |
|
|
| 2001P-0334
|
| Revoke Invalid FDA Regulations
|
| |
|
|
| RET 1
|
| 88-07-0027 Box 3
|
| Vol #:
|
| 1
|
| |
|
|
| 2001P-0343
|
| Metal/Metal Semi-Constrained Hip Joint Prosthesis
|
| |
|
|
| RET 1
|
| 88-07-0027 Box 3
|
| Vol #:
|
| 5
|
| |
|
|
| 2002P-0026
|
| ANDA for Paclitaxel, ANDA 75-184
|
| |
|
|
| RET 1
|
| 88-07-0027 Box 4
|
| Vol #:
|
| 3
|
| |
|
|
| 2002P-0033
|
| Carbidopa & Levodopa Orally Disintegrating Tablets
|
| |
|
|
| RET 1
|
| 88-07-0027 Box 4
|
| Vol #:
|
| 1
|
| |
|
|
| 2002P-0043
|
| Determine Pipracil Was Withdrawn For Safety Reasons
|
| |
|
|
| RET 1
|
| 88-07-0027 Box 4
|
| Vol #:
|
| 1
|
| |
|
|
| 2002P-0059
|
| Refrain from Approving ANDA for Isotretinoin Drug Products
|
| |
|
|
| RET 1
|
| 88-07-0027 Box 4
|
| Vol #:
|
| 1
|
|
| |
|
| 2002P-0078
|
| ANDA for Baclofen Orally Disintegrating Tablets, 10 mg & 20
|
| |
|
|
| RET 1
|
| 88-07-0027 Box 4
|
| Vol #:
|
| 1
|
| |
|
|
| 2002P-0084
|
| ANADA for a generic version of trimethoprim & sulfadiazine c
|
| |
|
|
| RET 1
|
| 88-07-0027 Box 4
|
| Vol #:
|
| 1
|
| |
|
|
| 2002P-0105
|
| ANDA Suitability for Oxycodone and Acetaminophen Tablets
|
| |
|
|
| RET 1
|
| 88-07-0027 Box 4
|
| Vol #:
|
| 1
|
| |
|
|
| 2002P-0127
|
| Determine if Phenergan has been withdrawn or withheld from s
|
| |
|
|
| RET 1
|
| 88-07-0027 Box 4
|
| Vol #:
|
| 1
|
| |
|
|
| 2002P-0141
|
| ANDA for 1.2 mg estropipate (1.2 mg sodium estrone sulfate)
|
| |
|
|
| RET 1
|
| 88-07-0027 Box 4
|
| Vol #:
|
| 1
|
| |
|
|
| 2002P-0148
|
| ANDA for Fenofibrate Tablets (Tricor)
|
|
| | | | | | | | |
|
| |
|
| RET 1
|
| 88-07-0027 Box 4
|
| Vol #:
|
| 1
|
| |
|
|
| 2002P-0161
|
| ANDA Suitability for Isotretinoin Capsules 30 mg
|
| |
|
|
| RET 1
|
| 88-07-0027 Box 4
|
| Vol #:
|
| 1
|
|
| |
|
| 2002P-0170
|
| ANDAs relaying Permax as reference listed drug not be appove
|
| |
|
|
| RET 1
|
| 88-07-0027 Box 4
|
| Vol #:
|
| 2
|
| |
|
|
| 2002P-0317
|
| Recall Aspartame as a Neurotoxic Drug
|
| |
|
|
| EMC 780
|
| Mission Possible International
|
| Vol #:
|
| 10
|
| |
|
|
| EMC 781
|
| Mission Possible International
|
| Vol #:
|
| 10
|
| |
|
|
| EMC 782
|
| Mission Possible International
|
| Vol #:
|
| 10
|
| |
|
|
| EMC 783
|
| Mission Possible International
|
| Vol #:
|
| 10
|
| |
|
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
| |
|
|
| EMC 1463
|
| No Signature
|
| Vol #:
|
| 12
|
| |
|
|
| 2003N-0400
|
| Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
|
| |
|
|
| EREG 4
|
| American Association of Wildlife Veterinarians
|
| Vol #:
|
| 15
|
|
| |
|
| 2003N-0573
|
| Draft Animal Cloning Risk Assessment
|
| |
|
|
| EMC 149
|
| L. Braggiotti
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 150
|
| R. Carey
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 151
|
| G. Smith
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 152
|
| Food & Water Watch
|
| Vol #:
|
| 5
|
| |
|
|
| 2005N-0262
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| Submission of Chemistry, Manufacturing, and Controls Information in a New Drug Application Under the New Pharmaceutical Quality Assessment System; Notice of Pilot Program
|
| |
|
|
| LET 15
|
| Tibotec Inc
|
| Vol #:
|
| 2
|
| |
|
|
| 2005N-0279
|
| Food Labeling; Gluten-Free Labeling of Foods
|
| |
|
|
| EMC 311
|
| B Sachau
|
| Vol #:
|
| 32
|
| |
|
|
| EREG 50
|
| Santa Clarita Valley Celiac Support Group
|
| Vol #:
|
| 32
|
| |
|
|
| 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
|
|
|
|
|
|
|
| |
|
|
| EMC 13
|
| Hyman, Phelps & McNamara, P. C.
|
| Vol #:
|
| 6
|
| |
|
|
| 2005P-0411
|
| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
|
| |
|
|
| C 18277
|
| A. Jacobi
|
| Vol #:
|
| 198
|
| |
|
|
| 2006N-0187
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Survey of Health Care Professionals on the Food Safety and Nutrition Information that they Provide to Pregnant Women
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|
|
|
|
|
|
|
| | | | | | | | |
|
| |
|
| EMC 1
|
| B. Sachau
|
| Vol #:
|
| 1
|
| |
|
|
| 2006N-0352
|
| Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
|
| |
|
|
| EMC 1162
|
| T. Bolen
|
| Vol #:
|
| 31
|
|
| |
|
| 2007D-0020
|
| Medical Devices: Class II Special Controls Guidance Document: Oxygen Pressure Regulators and Oxygen Conserving Devices
|
| |
|
|
| EMC 1
|
| TESCOM Europe GMBH & Company, KG
|
| Vol #:
|
| 1
|
| |
|
|
| 2007N-0019
|
| Medical Devices; Anesthesiology Devices; Oxygen Pressure Regulators and Oxygen Conserving Devices
|
| |
|
|
| EMC 1
|
| TESCOM Europe GMBH & Company, KG
|
| Vol #:
|
| 1
|
| |
|
|
| 2007P-0079
|
| To sanction third party independent scientific analysis of zine gluconate (ZICAM) additional safety standards for the homeopathic industry
|
| |
|
|
| EMC 1
|
| K. Kerr-Kurland
|
| Vol #:
|
| 1
|
| |
|
|
| 2007P-0110
|
| To enforce pediatric exclusivity rights for amlodipine
|
| |
|
|
| ACK 1
|
| FDA/DDM to Pfizer Inc
|
| Vol #:
|
| 1
|
| |
|
|
| CP 1
|
| Pfizer Inc
|
| Vol #:
|
| 1
|
| |
|
|
| 2007P-0111
|
| Stay approval of any and all supplements to Lotrel concerning amlodipine and pediatric exclusivity
|
| |
|
|
| ACK 1
|
| FDA/DDM to Pfizer Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| PSA 1
|
| Pfizer Inc.
|
| Vol #:
|
| 1
|
|
| |
|
| 2007P-0112
|
| Stay the implementation of recommendations currently being provided by CDER staff to companies concerning conduct of clinical trials and proposed statistical analyses for the efficacy requirements of
|
|
|
|
|
|
|
| |
|
|
| ACK 1
|
| FDA/DDM to Foley & Lardner LLP
|
| Vol #:
|
| 1
|
| |
|
|
| CP 1
|
| Three-Laboratory Consortium
|
| Vol #:
|
| 1
|
|
|
