| | | | | | | | | | |
|
|
|
|
| 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| Re-Listing Petition to determine that two strenghths, 50 mg and 250 mg lamotrigene oral tablets, were not withdrawn due to safety nor efficacy concerns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| Re-Listing Petition to determine that two strenghths, 50 mg and 250 mg lamotrigene oral tablets, were not withdrawn due to safety nor efficacy concerns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
|
|
