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| Dockets Entered
On November 2, 2007
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| Docket #
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| Title
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| 1978N-0038
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| Sunscreen Drug Products
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 2002N-0278
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| Bioterrorism; Prior Notice of Imported Food Shipments
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| 2006N-0168
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| Food Labeling: Reference Daily Intakes & Daily Reference Values
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| 2006P-0351
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| Restriction or withdrawal of the use of angiotensin converting enzyme inhibitor (ACEI) and angiotensin receptor blocker (ARB) therapy in the following conditions
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| 2007D-0310
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| Companion to Guidance for Industry on Pharmacogenomic Data
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| 2007H-0433
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| Civil Money Penalty; Advanced Bionics Corporation
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| 2007N-0121
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| Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing
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| 2007N-0262
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| Use of Ozone-Depleting Substances; Removal of Essential-Use Designation (Epinephrine)
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| 2007N-0343
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| Electronic Nonclinical Study Data Submission; Notice of Pilot Project
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| 2007N-0356
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| BEHIND THE COUNTER AVAILABILITY OF CERTAIN DRUGS; Public Meeting
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| 2007N-0389
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| Granisetron Hydrochloride Injection and 180-day generic drug exclusivity
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| 2007P-0085
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| Adopt Regulations of General Applicability to all Food Standards that would Permit Deviations from the Requirements of the Individual Food Standards of Identity
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| 2007P-0172
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| Determine whether Minocycline Hydrocholoride, Minocin Capsules EQ 75 mg Base Manufactures by Triax Pharmaceuticals, Ltd., has been voluntarily withdrawn from sale for safety or efficacy reasons.
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| 2007P-0209
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| Not to grant final ANDA approval for any generic versions of Toprol-XL, metoprolol succinate extended-release tablets (metoprolol) 50, mg
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| 2007P-0320
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| Regulation or Guideline to Label Medical Devices that Leach DEHP Plasticizers
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| 2007P-0431
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| Determine whether levomethadyl acetate HCI (Orlaam) NDA-20-315 has been voluntarily withdrawn from sale for safety or efficacy reasons.
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| 2007P-0434
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| To take the actions refrain from approving a recombinant thrombin biologies license application BLA
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| 1978N-0038
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| Sunscreen Drug Products
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| EC 2610
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| Mr. Randy Earl
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| Vol #:
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| 162
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| EC 2611
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| Mr. John Cooper
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| Vol #:
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| 162
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| EC 2612
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| Mrs. wanda wells
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| Vol #:
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| 162
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| EC 2613
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| Mrs. Ashley Eisenlohr
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| Vol #:
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| 162
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| EC 2614
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| Mrs. Nicole Hillman
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| Vol #:
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| 162
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| EC 2615
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| Ms. Julie Kuhn
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| Vol #:
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| 162
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| EC 2616
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| Limitedbrands, Inc.
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| Vol #:
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| 162
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| EC 2617
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| Mrs. NANCY EARL
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| Vol #:
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| 162
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| EC 2618
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| Mrs. Tina Guadagno
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| Vol #:
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| 162
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| EC 2619
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| Ciba
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| Vol #:
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| 162
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| EC 2620
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| Mrs. Deborah Costanzo
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| Vol #:
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| 162
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| EC 2621
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| Ciba Corporation
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| Vol #:
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| 162
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| EC 2622
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| Ms. SandraElizabeth Gresham
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| Vol #:
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| 162
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| EC 2623
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| Mrs. Virginia Flanders
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| Vol #:
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| 162
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| EC 2624
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| Obagi Medical Products
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| Vol #:
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| 162
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| EC 2625
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| Mrs. FLORENCE ERIKSSON
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| Vol #:
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| 162
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| C 1
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| NOVARTIS
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| Vol #:
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| 1
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| 2007H-0433
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| Civil Money Penalty; Advanced Bionics Corporation
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| LET 1
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| FDA/CDRH/OGC to Advanced Bionics Corporation
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| 1
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| 2007N-0121
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| Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing
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| C 13
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| Heathcare Compliance Packaging Council
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| Vol #:
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| 7
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| 2007N-0262
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| Use of Ozone-Depleting Substances; Removal of Essential-Use Designation (Epinephrine)
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| C 4
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| American Association for Respiratory Care
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| Vol #:
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| 1
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| 2007N-0343
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| Electronic Nonclinical Study Data Submission; Notice of Pilot Project
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| LET 1
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| Pfizer
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| Vol #:
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| 1
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| 2007N-0356
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| BEHIND THE COUNTER AVAILABILITY OF CERTAIN DRUGS; Public Meeting
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| EC 30
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| Mr. shibu john
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| Vol #:
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| 1
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| 2007N-0389
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| Granisetron Hydrochloride Injection and 180-day generic drug exclusivity
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| C 3
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| D. G. Adams
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| Vol #:
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| 1
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| 2007P-0085
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| Adopt Regulations of General Applicability to all Food Standards that would Permit Deviations from the Requirements of the Individual Food Standards of Identity
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| C 348
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| A. Lin
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| Vol #:
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| 102
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| C 349
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| J. Carlone
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| Vol #:
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| 102
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| 2007P-0172
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| Determine whether Minocycline Hydrocholoride, Minocin Capsules EQ 75 mg Base Manufactures by Triax Pharmaceuticals, Ltd., has been voluntarily withdrawn from sale for safety or efficacy reasons.
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| LET 1
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| Jane A. Axelrad
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| Vol #:
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| 1
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| 2007P-0209
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| Not to grant final ANDA approval for any generic versions of Toprol-XL, metoprolol succinate extended-release tablets (metoprolol) 50, mg
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| C 1
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| SANDOZ, Inc.
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| Vol #:
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| 1
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| 2007P-0320
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| Regulation or Guideline to Label Medical Devices that Leach DEHP Plasticizers
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| EC 18
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| Memorial Healthcare System
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| Vol #:
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| 1
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| EC 19
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| Ms. Marilyn Hubley
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| Vol #:
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| 1
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| 2007P-0431
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| Determine whether levomethadyl acetate HCI (Orlaam) NDA-20-315 has been voluntarily withdrawn from sale for safety or efficacy reasons.
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| ACK 1
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| FDA/DDM to Epidemiology and Community Health vcu School of Medicine
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| Vol #:
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| 1
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| CP 1
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| Epidemiology and Community Health vcu School of Medicine
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| Vol #:
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| 1
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| 2007P-0434
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| To take the actions refrain from approving a recombinant thrombin biologies license application BLA
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| ACK 1
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| FDA/ DDM/ to King Pharmaceuticals, Inc
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| Vol #:
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| 1
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| CP 1
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| King Pharmaceuticals, Inc
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| Vol #:
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| 1
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