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| Dockets Entered
On July 20, 2004
Table of Contents
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| Docket #
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| Title
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| 1981N-0033A
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| Oral Health Care Drug
Product; Oral Antiseptic Drug Products
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|
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| 1981P-0001
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| Laser Lumia projection
system
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|
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| 1989V-0166
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| Laser light show using
LFX-2 projector
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|
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|
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| 1994P-0390
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| Adopt Amendments Governing
Health Claims & Nutrient Claims
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|
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|
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| 1995P-0241
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| Implied Nutrient Content
Claim 'Healthy' & Health Claims
|
|
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| 1997V-0470
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| Lazer Light Show
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|
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| 1998D-0785
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| Medical imaging drugs
and biologics
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|
|
|
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| 1999P-5106
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| Identify Sources of
Natural Flavorings
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|
|
|
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| 2000N-1571
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| Enrofloxacin for Poultry:
Opportunity for Hearing
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|
|
|
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| 2001P-0075
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| Switch Status of Emergency
Contraceptives from Rx to OTC
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|
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| 2002N-0278
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| Bioterrorism; Prior
Notice of Imported Food Shipments
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|
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| 2002P-0233
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| Hydrocodone Bitartrate/Acetaminophen
orally 5mg/500mg ANDA
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| 2003M-0333
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| STAR S4 ActiveTrak Excimer
Laser System and WaveScan WaveFront System
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| 2003N-0324
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| New Animal Drugs; Removal
of Obsolete and Redundant Regulations
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| 2003N-0341
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| Requirements for Submission
of In Vivo Bioequivalence Data
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| 2003P-0029
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| Remove metered-dose
inhalers (MDI) containing moiety albuter
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|
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| 2003P-0551
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| Citalopram Hydrobromide
Capsules
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|
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| 2004D-0193
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| Guidance for Industry:
Eligibility Determination for Donors of Human Cells, Tissues, and Cellular
and Tissue-Based Products (HCT/Ps)
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| 2004D-0228
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| Guidance for Industry
on Fixed Dose Combination and Co-Packaged Drug Products for Treatment
of HIV'
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| 2004E-0325
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| Patent Extension for
Myfortic (mycophenolic acid) Delayed-Release Tablets, U.S. Patent No.
6,306,900
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|
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| 2004M-0309
|
| P020023 - Restylane
Injectable Gel, Approved 12/12/03
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|
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| 2004N-0081
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| BSE Risk Materials in
Foods and Cosmetics
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|
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| 2004N-0181
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| Critical Path Initiative
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|
|
|
|
| 2004P-0037
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| 513(f) Reclassification
Petition for TV-TIP Sound Amplifier
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| 2004P-0059
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| Health Claim Petition:
Glucosamine and Chondroitin Sulfate and Osteoarthritis
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| 2004P-0247
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| Escitalopram oxalate
may be filed for ANDA capsule dosage form
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| 2004P-0324
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| ANDA field by Ivax Pharmaceuticals
for a generic formulation of DuoNeb to a 30-month stay
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| 2004S-0233
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| Stimulating Innovation
in Medical Technologies
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| 1981N-0033A
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|
| | | | | | | | |
| |
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|
| Oral Health Care Drug Product; Oral Antiseptic Drug Products
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| |
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| C
5
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| Schering-Plough HealthCare Products
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| Vol #:
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| 17
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| |
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| CR
1
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| Schering-Plough HealthCare Products
|
| Vol #:
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| 17
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| |
|
|
| 1981P-0001
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| Laser Lumia projection system
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| |
|
|
| VRA
11
|
| HFZ-300 to Lighting Systems Design, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 1989V-0166
|
| Laser light show using LFX-2 projector
|
| |
|
|
| VRA
8
|
| HFZ-300 to Sea World of Texas
|
| Vol #:
|
| 1
|
| |
|
|
| 1994P-0390
|
| Adopt Amendments Governing Health Claims & Nutrient Claims
|
| |
|
|
| C
65
|
| Center for Science in the Public Interest
|
| Vol #:
|
| 7
|
| |
|
|
| 1995P-0241
|
| Implied Nutrient Content Claim 'Healthy' & Health Claims
|
| |
|
|
| C
82
|
| Center for Science in the Public Interest (CSPI)
|
| Vol #:
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| 9
|
| |
|
|
| 1997V-0470
|
| Lazer Light Show
|
| |
|
|
| VRA
3
|
| HFZ-300 to Lazer Onyx
|
| Vol #:
|
| 1
|
| |
|
|
| 1998D-0785
|
| Medical imaging drugs and biologics
|
| |
|
|
| C
31
|
| University of Southern California (USC)
|
| Vol #:
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| 6
|
| |
|
|
| 1999P-5106
|
| Identify Sources of Natural Flavorings
|
| |
|
|
| C 24
|
| A. Spanhel
|
| Vol #:
|
| 2
|
| |
|
|
| C 25
|
| C. Paule
|
| Vol #:
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| 2
|
| |
|
|
| C 26
|
| B. Bonsignore
|
| Vol #:
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| 2
|
| |
|
|
| C 27
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| C. Martineau
|
| Vol #:
|
| 2
|
| |
|
|
| C 28
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| G. Naccarato
|
| Vol #:
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| 2
|
| |
|
|
| C 29
|
| P. Brant
|
| Vol #:
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| 2
|
| |
|
|
| C 30
|
| J. Silverberg
|
| Vol #:
|
| 2
|
| |
|
|
| C 31
|
| A. Sturm
|
| Vol #:
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| 2
|
| |
|
|
| 2000N-1571
|
| Enrofloxacin for Poultry: Opportunity for Hearing
|
| |
|
|
| C
260
|
| Allen's Hatchery, Inc.
|
| Vol #:
|
| 99
|
| |
|
|
| 2001P-0075
|
| Switch Status of Emergency Contraceptives from Rx to OTC
|
| |
|
|
| EMC 7779
|
| M. Mak
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7780
|
| N. Arendt
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7781
|
| C. Wagner
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7782
|
| G. Chaffee
|
| Vol #:
|
| 280
|
|
| | | | | | | |
|
| |
|
| EMC 7783
|
| M. Sydney
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7784
|
| W. Windham
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7785
|
| L. Thompson
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7786
|
| M. Hansen
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7787
|
| R. Deutsch
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7788
|
| N. Sullivan
|
| Vol #:
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| 280
|
| |
|
|
| EMC 7789
|
| R. Nakamura
|
| Vol #:
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| 280
|
| |
|
|
| EMC 7790
|
| P. DiLieto
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7791
|
| K. Lavery
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7792
|
| s. Lingafelter
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7793
|
| C. Sennett
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7794
|
| J. Karno
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7795
|
| P. M. Cocks
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7796
|
| S. Gulati
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7797
|
| B. Satan
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7798
|
| M. L. Tabin
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7799
|
| C. Castellucci
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7800
|
| E. J. Rabinowitz
|
| Vol #:
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| 280
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| |
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|
| EMC 7801
|
| R. Anshell
|
| Vol #:
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| 280
|
| |
|
|
| EMC 7802
|
| R. Milewski
|
| Vol #:
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| 280
|
| |
|
|
| EMC 7803
|
| E. A. Belcher
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7804
|
| L. Theodore
|
| Vol #:
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| 280
|
| |
|
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| EMC 7805
|
| L. Rogers
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7806
|
| D. H. Goodrow
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7807
|
| M. Moiseyev
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7808
|
| Q. Wedee
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7809
|
| W. Ray
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7810
|
| K. Gallin
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7811
|
| Q. Gonzalez
|
| Vol #:
|
| 280
|
| |
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|
| EMC 7812
|
| C. Casper
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7813
|
| S. Pic
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7814
|
| S. Pic
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7815
|
| J. Harripaul
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7816
|
| C. Ponti
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7817
|
| D. E. Miller
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7818
|
| M. Nelson
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7819
|
| M. D. jMurray
|
| Vol #:
|
| 280
|
|
| | | | | | | |
| |
|
|
| EMC 7820
|
| E. Altshuler
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7821
|
| M. D. Martin
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7822
|
| K. Woodward
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7823
|
| M. Liebert
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7824
|
| B. Sevigny
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7825
|
| C. Absher
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7826
|
| A. Moumin
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7827
|
| D. N. Oliveira
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7828
|
| S. Lin
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7829
|
| A. Moumin
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7830
|
| R. A. Gray
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7831
|
| S. Bash
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7832
|
| L. De Niscia
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7833
|
| C. Redding
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7834
|
| L. Loewi
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7835
|
| E. J. Hallberg
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7836
|
| S. Bell
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7837
|
| J. Cole
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7838
|
| s. Lehan
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7839
|
| M. Dunstan
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7840
|
| J. Setele
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7841
|
| L. Lane
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7842
|
| L. Friedman
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7843
|
| J. A. Lewis
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7844
|
| C. A. Goldstein
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7845
|
| H. L. Vanderheiden
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7846
|
| B. Barlow
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7847
|
| D. Moore
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7848
|
| J. Jashni
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7849
|
| M. Wolfe
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7850
|
| A. Scarcella
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7851
|
| M. Batchelder
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7852
|
| A. Bucek
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7853
|
| J. Mason
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7854
|
| E. Reilly
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7855
|
| O. Gradess
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7856
|
| C. Scally
|
| Vol #:
|
| 280
|
|
| | | | | | | |
| |
|
|
| EMC 7857
|
| T. Willemsen
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7858
|
| N. Birthmark
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7859
|
| R. Egdall
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7860
|
| L. Lawson
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7861
|
| T. Igarashi
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7862
|
| S. Campbell
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7863
|
| J. LaDue
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7864
|
| T. S. Brickman
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7865
|
| E. Conte
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7866
|
| E. Hoffman
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7867
|
| J. Strain
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7868
|
| A. R. Shemberg
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7869
|
| C. Arnold
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7870
|
| J. Block
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7871
|
| T. Arpawong
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7872
|
| T. Widger
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7873
|
| L. M. Johnson
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7874
|
| R. Pollycove
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7875
|
| C. Hirsch
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7876
|
| A. Paes
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7877
|
| L. Forston
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7878
|
| A. Norton
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7879
|
| J. Lee
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7880
|
| B. Thompson
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7881
|
| D. Garrison
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7882
|
| B. Santee
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7883
|
| L. LaBrant
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7884
|
| J. Davey
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7885
|
| D. Stevens
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7886
|
| L. M. Henley
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7887
|
| K. Wamsley
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7888
|
| L. Price
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7889
|
| M. A. Fratelli
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7890
|
| R. Belulovich
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7891
|
| S. McGurn
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7892
|
| R. Janusko
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7893
|
| M. Solovay
|
| Vol #:
|
| 280
|
|
| | | | | | | |
| |
|
|
| EMC 7894
|
| K. McKee
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7895
|
| S. Seaborne
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7896
|
| K. Roesel
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7897
|
| P. Livingston
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7898
|
| P. Rothenberg
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7899
|
| R. M. Seltzer
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7900
|
| A. Boydstun
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7901
|
| K. Wroblewski
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7902
|
| R. Hupf
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7903
|
| C. Sewell
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7904
|
| K. Ross
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7905
|
| V. Neil
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7906
|
| C. Shultz
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7907
|
| L. Sharlow
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7908
|
| M. Miller
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7909
|
| L. Farrell
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7910
|
| E. Cattaneo
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7911
|
| J. H. Mahon
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7912
|
| L. Heckman
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7913
|
| P. C. Reilly & M. A. Flannery
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7914
|
| K. f. Benson
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7915
|
| B. Chapin
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7916
|
| A. Neil
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7917
|
| R. Rogers
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7918
|
| P. Preston-Roberts
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7919
|
| H. Smartt
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7920
|
| B. R. Perkins
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7921
|
| R. C. Nelson
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7922
|
| E. Lindner
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7923
|
| M. Embrey
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7924
|
| M. Carter
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7925
|
| L. Kwiatek
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7926
|
| E. Gough
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7927
|
| P. Allgood
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7928
|
| P. Gabris
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7929
|
| D. Phelan
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7930
|
| H. Martinez
|
| Vol #:
|
| 280
|
|
| | | | | | | |
| |
|
|
| EMC 7931
|
| T. Rogowski
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7932
|
| K. Heinrichs
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7933
|
| K. Campbell
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7934
|
| R. Keiser
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7935
|
| J. Rokicki
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7936
|
| C. Spear
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7937
|
| S. Cagno
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7938
|
| S. Whiting
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7939
|
| Dr. S. Rothenberg
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7940
|
| J. Olmsted
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7941
|
| M. A. McMinn
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7942
|
| C. Sabo
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7943
|
| S. A.O. Isenberg
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7944
|
| T. M. Hager
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7945
|
| L. Rezek
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7946
|
| H. Smith
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7947
|
| Z. Zimmerman
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7948
|
| E. Rosciam
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7949
|
| T. Bescher
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7950
|
| J. Leannah-Brumm
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7951
|
| J. Clark
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7952
|
| R. Kurlantzick
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7953
|
| M. Irvine
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7954
|
| K. Seger
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7955
|
| E. E. Douglas
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7956
|
| S. Douglas
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7957
|
| P. S. Collins
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7958
|
| J. Perry
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7959
|
| M. C. Irving
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7960
|
| A. Lemmert
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7961
|
| E. J. Murphy
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7962
|
| S. Korpi
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7963
|
| D. A. Deoliveira
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7964
|
| J. Conner
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7965
|
| A. Cooper
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7966
|
| S. Hahn
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7967
|
| N. Petrov
|
| Vol #:
|
| 280
|
|
| | | | | | | | |
| |
|
|
| EMC 7968
|
| R. Kelton
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7969
|
| J. Duryea
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7970
|
| M. Lederman
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7971
|
| H. Wagner
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7972
|
| B. Palmer
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7973
|
| H. Lips
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7974
|
| K. Brown
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7975
|
| A. Lynn
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7976
|
| K. Kirby
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7977
|
| S. Baker
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7978
|
| K. H. Backman
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7979
|
| L. Foley-Pellicani
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7980
|
| J. Jackson
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7981
|
| C. H. Whalen
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7982
|
| P. Marshall
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7983
|
| B. Wilcox
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7984
|
| J. Loring
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7985
|
| T. Ferro
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7986
|
| I. Krakauer
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7987
|
| M. Graver
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7988
|
| K. E. Johnson
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7989
|
| J. Mateja
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7990
|
| P. Stakelon
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7991
|
| R. & J. Jacobson
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7992
|
| J. Whitley
|
| Vol #:
|
| 280
|
| |
|
|
| EMC 7993
|
| B. Brown
|
| Vol #:
|
| 280
|
| |
|
|
| 2002N-0278
|
| Bioterrorism; Prior Notice of Imported Food Shipments
|
| |
|
|
| C
363
|
| I.E. Canada, Canadian Assn of Importers and Exporters Inc.
|
| Vol #:
|
| 30
|
| |
|
|
| C
364
|
| Sunbury Transport Limited, New Brunswick Southern Railway Company Limited et al.
|
| Vol #:
|
| 30
|
| |
|
|
| 2002P-0233
|
| Hydrocodone Bitartrate/Acetaminophen orally 5mg/500mg ANDA
|
| |
|
|
| LET
2
|
| HFD-600 to Kleinfeld, Kaplan and Backer
|
| Vol #:
|
| 1
|
| |
|
|
| 2003M-0333
|
| STAR S4 ActiveTrak Excimer Laser System and WaveScan WaveFront System
|
| |
|
|
| CR
1
|
| VISX, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2003N-0324
|
| New Animal Drugs; Removal of Obsolete and Redundant Regulations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| C 1
|
| Number not used
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003N-0341
|
| Requirements for
Submission of In Vivo Bioequivalence Data
|
|
|
|
|
| M
1
|
| HFD-560
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003P-0029
|
| Remove metered-dose
inhalers (MDI) containing moiety albuter
|
|
|
|
|
| C
20
|
| GlaxoSmithKline (GSK)
|
| Vol #:
|
| 2
|
|
|
|
|
| 2003P-0551
|
| Citalopram Hydrobromide
Capsules
|
|
|
|
|
| LET
2
|
| HFD-600 to Frommer Lawrence &
Haug, LLP
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004D-0193
|
| Guidance for Industry:
Eligibility Determination for Donors of Human Cells, Tissues, and Cellular
and Tissue-Based Products (HCT/Ps)
|
|
|
|
|
| C
2
|
| Xytex Corporation
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004D-0228
|
| Guidance for Industry
on Fixed Dose Combination and Co-Packaged Drug Products for Treatment
of HIV'
|
|
|
|
|
| C
3
|
| HIV Medicine Assn (HIVMA)
|
| Vol #:
|
| 1
|
|
|
|
|
| C
4
|
| Pharmaceutical research and Manufacturers
of America (PhRMA)
|
| Vol #:
|
| 1
|
|
|
|
|
| C
5
|
| Bristol-Myers Squibb (BMS)
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004E-0325
|
| Patent Extension
for Myfortic (mycophenolic acid) Delayed-Release Tablets, U.S. Patent
No. 6,306,900
|
|
|
|
|
| APP
1
|
| Novartis
|
| Vol #:
|
| 1
|
|
|
|
|
| LET
1
|
| U.S. Patent & Trademark Office
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004M-0309
|
| P020023 - Restylane
Injectable Gel, Approved 12/12/03
|
|
|
|
|
| AAV
1
|
| Q-Med Scandinavia, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0081
|
| BSE Risk Materials
in Foods and Cosmetics
|
|
|
|
|
| REF
1
Tab A, B,
C
|
| OMB Review for July 14, 2004
|
| Vol #:
|
| 6
|
|
|
|
|
| 2004N-0181
|
| Critical Path Initiative
|
|
|
|
|
| C
3
|
| National Organization for Rare
Disorders, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| 2004P-0037
|
| 513(f) Reclassification
Petition for TV-TIP Sound Amplifier
|
|
|
|
|
| C
1
|
| Academy of Dispensing Audiologists
(ADA)
|
| Vol #:
|
| 2
|
|
|
|
|
| 2004P-0059
|
| Health Claim Petition:
Glucosamine and Chondroitin Sulfate and Osteoarthritis
|
|
|
|
|
| ANS
1
|
| HFS-800 to Emord & Associates,
P.C.
|
| Vol #:
|
| 13
|
|
|
|
|
| 2004P-0247
|
| Escitalopram oxalate
may be filed for ANDA capsule dosage form
|
|
|
|
|
| ANS
1
|
| HFD-600 to Frommer Lawrence &
Haug, LLP
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004P-0324
|
| ANDA field by Ivax
Pharmaceuticals for a generic formulation of DuoNeb to a 30-month stay
|
|
|
|
|
| ACK
1
|
| HFA-305 to Dey, L.P.
|
| Vol #:
|
| 1
|
|
|
|
|
| CP
1
|
| Dey, L.P.
|
| Vol #:
|
| 11
|
|
|
|
|
| 2004S-0233
|
| Stimulating Innovation
in Medical Technologies
|
|
|
|
|
| C
1
|
| Ethicon Endo-Surgery, Inc.
|
| Vol #:
|
| 1
| |
|
