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| Dockets Entered
On January 6, 2006
Table of Contents
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| Docket #
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| Title
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| 1995S-0158
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| Community Disclosure of Institutional Review Boards
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| 2001N-0548
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| Guidelines for Voluntary Nutrition Labeling of Raw Fruits
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| 2002N-0273
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| Animal Proteins Prohibited in Ruminant Feed
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| 2003P-0132
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| Part 135 FDA regulations standard of identity frozen dessert
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| 2004N-0556
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| Obstetrical and Gynecological Devices; Designation of Special Control for Condom and Condom with Spermicidal Lubricant
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| 2004P-0202
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| Notify State & Federal regulators of GRAS requirements of milk protein Concentrate
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| 2004P-0294
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| Health Claim Petition: Noncariogenicity Dental Health Claim for Sucralose
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| 2005D-0330
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| Guidance for Industry and FDA Review Staff on Collection of Platelets by Automated Methods
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| 2005D-0391
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| Guidance for Industry and Food and Drug Administration Staff; Functional Indications for Implantable Cardioverter Defibrillators
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| 2005N-0220
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components; and Requirements for Donor
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| 2005N-0354
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| Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
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| 2005N-0374
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| Use of Ozone-Depleting Substance: Essential-Use Determination of Over the Counter Epinephrine Metered-Dose Inhalers
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| 2005N-0479
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| International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Butorphanol; Delta-9-tetrahydrocannabinol (Dronabinol); Gamma-Hydroxybutyric Acid; Ketamine;
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| 2005N-0500
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Requirements for Collection of Data Relating to the Prevention of Medical Gas Mix-ups at Health Care Facilities - Survey
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| 2005P-0076
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| OxyContin and Paladone removal from market and label changes limiting indications to severe chronic pain
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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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| 2006E-0005
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| Patent Extension Application for Lyrica (pregabalin), U.S. Patent No. 6,001,876
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| 2006E-0006
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| Patent Extension Application for Lyrica (pregabalin), U.S. Patent No. 6,197,819
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| 2006E-0008
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| Patent Extension Application for DRAXXIN (tulathromycin), U.S. Patent No. 6,420,536
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| 2006P-0002
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| Methocarbamol Tablets USP, 1000 mg for Abbreviated new drug application (ANDA)
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| 2006P-0007
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| Oxycocone Hydrochloride and Acetaminophen Oral Solution, 10 mg/ 300 mg/5 mL.
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| 1995S-0158
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| Community Disclosure of Institutional Review Boards
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| SUP
48
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| Northfield Laboratories BB IND #10719
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| Vol #:
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| 51
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
17088
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| Apex Fitness Group
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| Vol #:
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| 154
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| LET
17089
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| Apex Fitness Group
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| Vol #:
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| 154
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| LET
17090
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| Enzymatic Therapy
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| Vol #:
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| 154
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| LET
17091
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| Enzymatic Therapy
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| Vol #:
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| 154
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| LET
17092
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| Enzymatic Therapy
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| Vol #:
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| 155
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| LET
17093
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| Enzymatic Therapy
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| Vol #:
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| 155
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| LET
17094
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| Enzymatic Therapy
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| Vol #:
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| 155
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| LET
17095
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| Enzymatic Therapy
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| Vol #:
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| 155
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| EMC 622
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| B. Witt
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| Vol #:
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| 24
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| EMC 623
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| B. Witt
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| Vol #:
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| 24
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| 2001N-0548
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| Guidelines for Voluntary Nutrition Labeling of Raw Fruits
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| EMC
24
Attachment
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| U.S. Apple Association (USApple)
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| Vol #:
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| 5
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| 2002N-0273
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| Animal Proteins Prohibited in Ruminant Feed
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| EMC 131
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| K. Cheek
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| Vol #:
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| 14
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| EMC 585
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| Mission Possible International
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| Vol #:
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| 9
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| EMC 586
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| Mission Possible International
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| Vol #:
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| 9
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| EMC 1187
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| M. Hallinan
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| Vol #:
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| 12
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| EMC 1188
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| B. Talmage
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| Vol #:
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| 12
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| EMC 1189
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| K. Hayes
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| Vol #:
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| 12
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| EMC 1190
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| T. Hurley
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| Vol #:
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| 12
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| EMC 1191
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| Eligible
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| Vol #:
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| 12
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| EMC 1192
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| D. Varney
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| Vol #:
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| 12
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| 2003P-0132
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| Part 135 FDA regulations standard of identity frozen dessert
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| C 41
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| D. Herr
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| Vol #:
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| 2
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| 2004N-0556
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| Obstetrical and Gynecological Devices; Designation of Special Control for Condom and Condom with Spermicidal Lubricant
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| REF
1
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| OMB Review for Designation of Special Control for Condom and Condom with Spermicidal Lubrican
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| Vol #:
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| 3
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| 2004P-0202
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| Notify State & Federal regulators of GRAS requirements of milk protein Concentrate
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| C 13
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| L. Smith
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| Vol #:
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| 1
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| 2004P-0294
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| Health Claim Petition: Noncariogenicity Dental Health Claim for Sucralose
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| M
1
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| HFS-832
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| Vol #:
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| 2
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| 2005D-0330
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| Guidance for Industry and FDA Review Staff on Collection of Platelets by Automated Methods
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| C
36
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| Gulf Coast Regional Blood Center
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| Vol #:
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| 4
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| C
37
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| Indiana Blood Center
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| Vol #:
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| 4
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| C
38
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| Johnston Memorial Hospital
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| Vol #:
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| 4
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| C
39
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| Puget Sound Blood Center
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| Vol #:
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| 4
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| C 40
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| M. Johnson
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| Vol #:
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| 4
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| C
41
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| Community Blood Bank
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| Vol #:
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| 4
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| C
42
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| Michigan Community Blood Centers (MCBC)
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| Vol #:
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| 4
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| EMC
2
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| City of Hope National Medical Center
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| Vol #:
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| 4
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| EMC
3
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| New Jersey Blood Services
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| Vol #:
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| 4
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| EMC
4
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| Hoag Memorial Hospital Presbyterian
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| Vol #:
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| 4
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| 2005D-0391
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| Guidance for Industry and Food and Drug Administration Staff; Functional Indications for Implantable Cardioverter Defibrillators
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| C
2
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| Interventional Rhythm Management, Inc.
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| Vol #:
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| 1
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| 2005N-0220
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components; and Requirements for Donor
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| NAL
1
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| FDA
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| Vol #:
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| 1
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| SS
1
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| Supporing Statement
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| Vol #:
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| 1
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| 2005N-0354
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| Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
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| EMC 77
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| Ryan Arnold
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| Vol #:
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| 4
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| 2005N-0374
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| Use of Ozone-Depleting Substance: Essential-Use Determination of Over the Counter Epinephrine Metered-Dose Inhalers
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| C
1
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| The Assembly State of New York, Albany
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| Vol #:
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| 1
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| 2005N-0479
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| International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Butorphanol; Delta-9-tetrahydrocannabinol (Dronabinol); Gamma- Hydroxybutyric Acid; Ketamine;
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| EXT
1
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| Hyman, Phelps & McNamara, P.C.
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| Vol #:
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| 1
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| 2005N-0500
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Requirements for Collection of Data Relating to the Prevention of Medical Gas Mix-ups at Health Care Facilities - Survey
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| N
1
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| FDA
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| Vol #:
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| 1
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| 2005P-0076
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| OxyContin and Paladone removal from market and label changes limiting indications to severe chronic pain
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| EMC 1
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| L. Farris
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| Vol #:
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| 1
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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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| C 170
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| M. Guess
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| Vol #:
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| 3
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| C 171
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| T. Crawford
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| Vol #:
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| 3
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| C 172
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| S. Williams
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| Vol #:
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| 3
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| C 173
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| Dr. T. Fourre
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| Vol #:
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| 3
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| C 174
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| D. Bergin
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| Vol #:
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| 3
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| C 175
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| P. Fontaine
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| Vol #:
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| 3
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| C 176
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| J. Nichols
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| Vol #:
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| 3
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| C 177
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| K. Jeffries
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| Vol #:
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| 3
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| C 178
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| K. Albers
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| Vol #:
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| 3
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| C
179
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| Steven E. Pillow, M.D., P.A., FACOG and Associates
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| Vol #:
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| 3
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| C 180
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| J. Bell
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| Vol #:
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| 3
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| C 181
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| C. Hazel
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| Vol #:
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| 3
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| C 182
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| D. Minocchi
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| Vol #:
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| 3
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| C 183
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| P. Davis
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| Vol #:
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| 3
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| C 184
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| L. Ballard
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| Vol #:
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| 3
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| C 185
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| G. Howton
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| Vol #:
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| 3
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| C 186
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| Eligible
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| Vol #:
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| 3
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| C 187
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| P. Menser
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| Vol #:
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| 3
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| C 188
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| E. Wright
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| Vol #:
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| 3
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| C 189
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| P. Ayres
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| Vol #:
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| 3
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| C 190
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| C. Fisher
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| Vol #:
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| 3
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| EMC 2
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| M. Jacobs
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| Vol #:
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| 3
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| EMC 3
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| D. Barone
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| Vol #:
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| 3
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| EMC 4
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| S. Novas
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| Vol #:
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| 3
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| EMC 5
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| D. Doyle
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| Vol #:
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| 3
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| 2006E-0005
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| Patent Extension Application for Lyrica (pregabalin), U.S. Patent No. 6,001,876
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| APP
1
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| Warner-Lambert Company LLC
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| Vol #:
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| 1
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| LET
1
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| U.S. Patent & Trademark Office
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| Vol #:
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| 1
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| 2006E-0006
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| Patent Extension Application for Lyrica (pregabalin), U.S. Patent No. 6,197,819
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| APP
1
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| Warner-Lambert Company LLC
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| Vol #:
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| 1
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| LET
1
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| U.S. Patent & Trademark Office
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| Vol #:
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| 1
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| 2006E-0008
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| Patent Extension Application for DRAXXIN (tulathromycin), U.S. Patent No. 6,420,536
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| APP
1
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| Pfizer Inc.
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| Vol #:
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| 1
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| LET
1
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| U.S. Patent & Trademark Office
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| Vol #:
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| 1
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| 2006P-0002
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| Methocarbamol Tablets USP, 1000 mg for Abbreviated new drug application (ANDA)
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| ACK
1
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| HFA-305 to Lachman Conusltant Services, Inc.
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| Vol #:
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| 1
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| 2006P-0007
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| Oxycocone Hydrochloride and Acetaminophen Oral Solution, 10 mg/ 300 mg/5 mL.
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| ACK
1
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| HFA-305 to Lachman Consultant Services, Inc.
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| Vol #:
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| 1
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| CP
1
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| Lachman Consultant Services, Inc.
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| Vol #:
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| 1
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