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| Dockets Entered
On May 22, 2007
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| Docket #
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| Title
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| 2005E-0248
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| Patent Term Extension Application for Fosrenol, U.S. Patent No. 5,968,976
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| 2005E-0255
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| Patent Extension Application for LUNESTA (exzoplclone), U.S. Patent No. 6,444,673
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| 2006D-0480
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| Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration
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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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| 2007P-0209
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| Not to grant final ANDA approval for any generic versions of Toprol-XL, metoprolol succinate extendend-release tablets (metoprolol) 50, mg
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| 2007P-0210
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| Reclassification Petition for Human Papillomavirus (HPV) DNA Nested Polymerase Chain Reaction (PCR) Detection under Section 513(f), 21 CFR 860 Subpart C
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| 2005E-0248
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| Patent Term Extension Application for Fosrenol, U.S. Patent No. 5,968,976
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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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| 2005E-0255
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| Patent Extension Application for LUNESTA (exzoplclone), U.S. Patent No. 6,444,673
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| WDL 1
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| FDA/CDER to the U.S. Patent and Trademark Office
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| 1
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| 2006D-0480
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| Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration
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| NEC 1
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| FDA
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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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| EAPE 215
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| Jones, Jovonne
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| Vol #:
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| 7
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| EAPE 216
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| Liversidge, Ellen
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| Vol #:
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| 7
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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 extendend-release tablets (metoprolol) 50, mg
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| ACK 1
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| FDA/DDM to Sandoz Inc.
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| 1
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| CP 1
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| Sandoz Inc.
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| Vol #:
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| 1
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| 2007P-0210
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| Reclassification Petition for Human Papillomavirus (HPV) DNA Nested Polymerase Chain Reaction (PCR) Detection under Section 513(f), 21 CFR 860 Subpart C
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| ACK 1
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| HiFi DNA Tech, LLC
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| Vol #:
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| 1
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| CCP 1
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| HiFi DNA Tech, LLC
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| Vol #:
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| 1
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