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Dockets Management

Dockets Entered On May 22, 2007
Docket # Title
2005E-0248 Patent Term Extension Application for Fosrenol, U.S. Patent No. 5,968,976
2005E-0255 Patent Extension Application for LUNESTA (exzoplclone), U.S. Patent No. 6,444,673
2006D-0480 Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration
2007N-0121 Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing
2007P-0209 Not to grant final ANDA approval for any generic versions of Toprol-XL, metoprolol succinate extendend-release tablets (metoprolol) 50, mg
2007P-0210 Reclassification Petition for Human Papillomavirus (HPV) DNA Nested Polymerase Chain Reaction (PCR) Detection under Section 513(f), 21 CFR 860 Subpart C
2005E-0248 Patent Term Extension Application for Fosrenol, U.S. Patent No. 5,968,976
N 1 FDA Vol #: 1
2005E-0255 Patent Extension Application for LUNESTA (exzoplclone), U.S. Patent No. 6,444,673
WDL 1 FDA/CDER to the U.S. Patent and Trademark Office Vol #: 1
2006D-0480 Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration
NEC 1 FDA Vol #: 1
2007N-0121 Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing
EAPE 215 Jones, Jovonne Vol #: 7
EAPE 216 Liversidge, Ellen Vol #: 7
2007P-0209 Not to grant final ANDA approval for any generic versions of Toprol-XL, metoprolol succinate extendend-release tablets (metoprolol) 50, mg
ACK 1 FDA/DDM to Sandoz Inc. Vol #: 1
CP 1 Sandoz Inc. Vol #: 1
2007P-0210 Reclassification Petition for Human Papillomavirus (HPV) DNA Nested Polymerase Chain Reaction (PCR) Detection under Section 513(f), 21 CFR 860 Subpart C
ACK 1 HiFi DNA Tech, LLC Vol #: 1
CCP 1 HiFi DNA Tech, LLC Vol #: 1

Page created on May 23, 2007 ue

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