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| Dockets Entered On January 05, 2006
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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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| 1999D-2215
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| Impurities in New Veterinary Drug Substances
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| 2004D-0468
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| Draft Guidance for Industry on Development of Target Animal Safety and Effectiveness Data to Support Approval of Non-Steroidal Anti-Inflammatory Drugs (NSAIDS) for use in Animals
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| 2004D-0493
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| Draft Guidance for Industry on Recommended Approaches to Integration of Genetic Toxicology Study Results
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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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| 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-0003
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| Patent Extension Application for BiDIL (combination of hydralazine hydrochloride and isosorbide dinitrate), U.S. Patent No. 4,868,179
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| 2006E-0004
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| Patent Extension Application for CYMBALTA (duloxetine hydrochloride), U.S. Patent No. 5,023,269
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
17072
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| Nikken, Inc.
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| Vol #:
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| 154
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| LET
17073
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| Aum Tea Company
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| Vol #:
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| 154
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| LET
17074
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| Natrol, Inc.
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| Vol #:
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| 154
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| LET
17075
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| Fuji Health Science, Inc.
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| Vol #:
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| 154
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| LET
17076
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| Fuji Health Sciences, Inc.
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| Vol #:
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| 154
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| LET
17077
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| P. L. Thomas & Company, Inc.
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| Vol #:
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| 154
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| LET
17078
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| RKS Inc.
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| Vol #:
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| 154
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| LET
17079
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| Arkopharma, LLC
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| Vol #:
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| 154
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| LET
17080
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| Arkopharma, LLC
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| Vol #:
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| 154
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| LET
17081
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| Arkopharma, LLC
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| Vol #:
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| 154
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| LET
17082
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| Chattern, Inc.
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| Vol #:
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| 154
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| LET
17083
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| Arkopharma, LLC
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| Vol #:
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| 154
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| LET
17084
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| Arkopharma, LLC
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| Vol #:
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| 154
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| LET
17085
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| Arkopharma, LLC
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| Vol #:
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| 154
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| LET
17086
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| Arkopharma, LLC
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| Vol #:
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| 154
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| LET
17087
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| Arkopharma, LLC
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| Vol #:
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| 154
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| 1999D-2215
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| Impurities in New Veterinary Drug Substances
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| GDL
3
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| Guideline
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| Vol #:
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| 1
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| NAD
3
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| FDA
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| Vol #:
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| 1
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| 2004D-0468
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| Draft Guidance for Industry on Development of Target Animal Safety and Effectiveness Data to Support Approval of Non-Steroidal Anti-Inflammatory Drugs (NSAIDS) for use in Animals
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| GDL
2
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| Guideline
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| Vol #:
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| 1
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| NAD
2
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| FDA
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| Vol #:
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| 1
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| 2004D-0493
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| Draft Guidance for Industry on Recommended Approaches to Integration of Genetic Toxicology Study Results
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| GDL
2
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| Guideline
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| Vol #:
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| 1
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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
26
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| Central Texas Regional Blood & Tissue Center
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| Vol #:
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| 4
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| C
27
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| Blood Bank of Alaska, Inc.
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| Vol #:
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| 4
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| C
28
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| Life Source Blood Services
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| Vol #:
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| 4
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| C
29
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| Central Blood Bank
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| Vol #:
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| 4
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| C 30
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| A. Hendra
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| Vol #:
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| 4
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| C 31
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| B. Nemacheck
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| Vol #:
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| 4
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| C 32
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| J. Rhoades
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| Vol #:
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| 4
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| C 33
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| D. Langsford
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| Vol #:
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| 4
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| C
34
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| New Jersey Blood Services
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| Vol #:
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| 4
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| C
35
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| San Diego Blood Bank
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| Vol #:
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| 4
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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 160
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| S. Fink
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| Vol #:
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| 3
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| C 161
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| N. Lindsey
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| Vol #:
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| 3
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| C 162
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| T. Douglas
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| Vol #:
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| 3
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| C 163
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| J. Rion
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| Vol #:
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| 3
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| C 164
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| C. Payne
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| Vol #:
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| 3
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| C 165
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| K. Knepp
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| Vol #:
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| 3
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| C 166
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| A. Ritchey
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| Vol #:
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| 3
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| C 167
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| D. Gregg
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| Vol #:
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| 3
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| C 168
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| D. Ray
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| Vol #:
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| 3
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| C 169
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| S. Schneider
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| Vol #:
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| 3
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| 2006E-0003
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| Patent Extension Application for BiDIL (combination of hydralazine hydrochloride and isosorbide dinitrate), U.S. Patent No. 4,868,179
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| APP
1
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| NitroMed, Inc.
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| Vol #:
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| 1
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| LET
1
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| U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2006E-0004
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| Patent Extension Application for CYMBALTA (duloxetine hydrochloride), U.S. Patent No. 5,023,269
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| APP
1
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| Eli Lilly and Company
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| Vol #:
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| 1
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| LET
1
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| U.S. Patent and Trademark Office
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| Vol #:
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| 1
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