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Dockets Management

Dockets Entered On March 5, 2007
Docket # Title
1990P-0084 Paraflex (chlorzoxazone) Drug Prod List for ANDA's
2003N-0573 Draft Animal Cloning Risk Assessment
2004P-0522 Off label drug use for CYTOTEC
2005P-0237 Re-Listing Petition to determine that two strenghths, 50 mg and 250 mg lamotrigene oral tablets, were not withdrawn due to safety nor efficacy concerns
2006D-0480 Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration
2006N-0427 Agency Information Collection Activities; Proposed Collection; Comment Request;
2006P-0484 Change the indication for Stimulant Medications for the Treatment of Mental Diseases
2007D-0020 Medical Devices: Class II Special Controls Guidance Document: Oxygen Pressure Regulators and Oxygen Conserving Devices
2007E-0001 Patent Extension Application for METVIXIA (methyl aminoevulinate hydrochloride), U.S. Patent No. 6,034,267
2007E-0012 Patent Extension Application for IONSYS (fentanyl iontophoretic transdermal system), U.S. Patent No. 6,425,892
2007E-0013 Patent Extension Application for IONSYS (fentanyl iontophoretic transdermal system), U.S. Patent No. 5,697,896
2007E-0046 Patent Extension Application for ZILMAX (zilpaterol hydrochloride), U.S. Patent No. 4,900,735
2007N-0051 Safety of Fresh Produce; Public Hearings
2007N-0053 Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling Regulations
2007N-0055 Arcoxia Arthritis Advisory Committee Meeting, April 12, 2007
2007N-0061 Sipuleucel-T Dendreon
1990P-0084 Paraflex (chlorzoxazone) Drug Prod List for ANDA's
NWL 1 FDA Vol #: 1
2003N-0573 Draft Animal Cloning Risk Assessment
C 277 Form Letter Count 19 Vol #: 24
C 278 Form Letter Count 25 signatures Vol #: 25
C 279 Form Letter Count 6 Vol #: 26
2004P-0522 Off label drug use for CYTOTEC
C 2 R. Avola Vol #: 1
2005P-0237 Re-Listing Petition to determine that two strenghths, 50 mg and 250 mg lamotrigene oral tablets, were not withdrawn due to safety nor efficacy concerns
N 1 FDA Vol #: 1
2006D-0480 Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration
GDL 1 Guidance Vol #: 1
2006N-0427 Agency Information Collection Activities; Proposed Collection; Comment Request;
N 2 FDA Vol #: 1
2006P-0484 Change the indication for Stimulant Medications for the Treatment of Mental Diseases
C 1 J. & A. Guerra Vol #: 1
2007D-0020 Medical Devices: Class II Special Controls Guidance Document: Oxygen Pressure Regulators and Oxygen Conserving Devices
GDL 1 Guidance Vol #: 1
NAD 1 FDA Vol #: 1
2007E-0001 Patent Extension Application for METVIXIA (methyl aminoevulinate hydrochloride), U.S. Patent No. 6,034,267
LET 2 FDA/CDER to the U.S. Patent and Trademark Office Vol #: 1
2007E-0012 Patent Extension Application for IONSYS (fentanyl iontophoretic transdermal system), U.S. Patent No. 6,425,892
LET 2 FDA/CDER to the U.S. Patent and Trademark Office Vol #: 1
2007E-0013 Patent Extension Application for IONSYS (fentanyl iontophoretic transdermal system), U.S. Patent No. 5,697,896
LET 2 FDA/CDER to the U.S. Patent and Trademark Office Vol #: 1
2007E-0046 Patent Extension Application for ZILMAX (zilpaterol hydrochloride), U.S. Patent No. 4,900,735
LET 2 FDA/CDER to the U.S. Patent and Trademark Office Vol #: 1
2007N-0051 Safety of Fresh Produce; Public Hearings
BKG 1 Background Material Vol #: 2
2007N-0053 Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling Regulations
N 1 FDA Vol #: 1
2007N-0055 Arcoxia Arthritis Advisory Committee Meeting, April 12, 2007
NM 1 FDA Vol #: 1
2007N-0061 Sipuleucel-T Dendreon
NM 1 FDA Vol #: 1

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