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| Dockets Entered
On April 8, 2004
Table of Contents
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| Docket #
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| Title
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| 1999D-0529
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| Draft Guidance for Ind
- Changes to an Approved NDA or ANDA
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| 1999N-0193
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| Supplements and Other
Changes to an Approved Application
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| 2001P-0075
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| Switch Status of Emergency
Contraceptives from Rx to OTC
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| 2002N-0204
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| Bar Code Label Requirements
for human drug products
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| 2003H-0432
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| Civil Money Penalty,
Korangy Radiology Associates, PA
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| 2003N-0463
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| Agency Information Collection
Activities: Proposed Collection; Comment Request; Infant Formula Requirements
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| 2003N-0507
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| Agency Emergency Processing
Request Under OMB Review; Experimental Study of Trans Fat Claims on
Foods
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| 2003P-0321
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| Refrain from approving
an Abbreviated New Drug Application (ANDA's) for Riavirin
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| 2003P-0555
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| Maintain the Electroconvulsive
Therapy Device in Class III for All Indications
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| 2004D-0002
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| Guidance for Industry and FDA
Staff; Saline, Silicone Gel, and Alternative Breast Implants
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| 2004D-0160
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| Use of Unapproved Hormone
Implants in Veal Calves
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| 2004N-0049
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| Agency Information Collection
Activities; Proposed Collection; Comment Request; Control of Communicable
Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain
Other Animals
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| 2004N-0093
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| Agency Information Collection
Activities: Registration of Producers of Drugs and Listing of Drugs
in Commercial Distribution , 21 CFR Part 207.
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| 2004N-0115
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| Prescription Drug Importation
Study
|
|
|
|
|
| 2004N-0133
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| Part 11, Electronic
Record; Electronic Signatures; Public Meeting
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|
|
|
|
| 2004P-0164
|
| Exemption from the medical
devices tracking requirements for Heartstream automated external defibrillators
|
|
|
|
|
| 2004P-0167
|
| ANADA for a generic
equivalent of the innovator products, Garacin (gentamicin sulfate) Pig
Pump Oral Solution
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|
|
|
|
| 2004P-0168
|
| ANDA Suitability for
Glipizide and Metformin Hydrochloride Oral Solution
|
|
|
|
|
| 2004P-0169
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| Erroneous Interpretation
of the Statutory Definition of the Term "Dietary Supplement"
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|
|
|
|
| 1999D-0529
|
| Draft Guidance for
Ind - Changes to an Approved NDA or ANDA
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|
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|
|
| GDL
3
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| Guideline
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| Vol #:
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| 5
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|
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|
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| NAD
3
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| FDA
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| Vol #:
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| 5
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|
|
|
|
| 1999N-0193
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| Supplements and Other
Changes to an Approved Application
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| NFR
1
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| FDA
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| Vol #:
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| 3
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| 2001P-0075
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| Switch Status of
Emergency Contraceptives from Rx to OTC
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| EC
651
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| T.O.R.C.H.
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| Vol #:
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| 163
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| EC 652
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| Mrs. Alice Manning
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| Vol #:
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| 163
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| EC 653
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| Mr. Rudy Quiroz
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| Vol #:
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| 163
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| EC 654
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| Mr. Christian Crampton
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| Vol #:
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| 163
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| EC 655
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| Miss. Patricia Hayes
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| Vol #:
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| 163
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| EC 656
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| Ms. CJ Wyckoff
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| Vol #:
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| 163
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| EC 657
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| Mrs. Ann Baker
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| Vol #:
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| 163
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| EC 658
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| Ms. Daina Ferguson
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| Vol #:
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| 163
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| EC 659
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| Mrs. Barbara Kralis
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| Vol #:
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| 163
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| EC 660
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| Mrs. Catherine Zellhofer
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| Vol #:
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| 163
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| EC 661
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| Ms. Jim Serafi
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| Vol #:
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| 163
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| EC 662
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| Mr. Bernard Pilon
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| Vol #:
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| 163
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| EC 663
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| Dr. Donald Perrella
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| Vol #:
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| 163
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| | | | | | | | |
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| EC 701
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| Mr. Trent B
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| Vol #:
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| 163
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| EC 702
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| Mrs. Christine Mukai
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| Vol #:
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| 163
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| EC 703
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| Mrs. Katherine Anderson
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| Vol #:
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| 163
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| EC 704
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| Mr. G. Edward Deery
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| Vol #:
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| 163
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| EC 705
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| Ms. Catherine Mollendor
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| Vol #:
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| 163
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| EC 706
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| The Wellington School
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| Vol #:
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| 163
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| 2002N-0204
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| Bar Code Label Requirements for human drug products
|
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| NCR
2
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| FDA
|
| Vol #:
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| 15
|
|
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| 2003H-0432
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| Civil Money Penalty, Korangy Radiology Associates, PA
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| CS
3
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| HFA-305 to Henry E. Schwartz LLC
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| Vol #:
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| 2
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|
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| MO
7
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| GCF-1
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| Vol #:
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| 2
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| OR
3
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| HF-3
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| Vol #:
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| 2
|
|
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| 2003N-0312
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| Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
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| EC 1
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| citizen
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| Vol #:
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| 4
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| 2003N-0463
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Infant Formula Requirements
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| NAL
1
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| FDA
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| Vol #:
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| 1
|
|
|
|
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| SS
1
|
| Guideline
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| Vol #:
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| 1
|
|
|
|
|
| 2003N-0507
|
| Agency Emergency Processing Request Under OMB Review; Experimental Study of Trans Fat Claims on Foods
|
|
|
|
|
| NAL
1
|
| FDA
|
| Vol #:
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| 1
|
|
|
|
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| SS
1
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| Supporting Statement
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| Vol #:
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| 1
|
|
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| 2003N-0513
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| Electronic Submissions of Food Contact Notifications; Notice of Pilot Project
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| EC 2
|
| Mr. Ed White
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| Vol #:
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| 1
|
|
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| 2003P-0321
|
| Refrain from approving an Abbreviated New Drug Application (ANDA's) for Riavirin
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|
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| PDN 1
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| HFD-1 to Hogan & Hartson, LLP
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| Vol #:
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| 3
|
|
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|
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| 2003P-0555
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| Maintain the Electroconvulsive Therapy Device in Class III for All Indications
|
|
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|
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| EC 16
|
| People Who
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| Vol #:
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| 2
|
|
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|
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| 2004D-0002
|
| Guidance for Industry and FDA Staff; Saline, Silicone Gel, and Alternative Breast Implants
|
|
|
|
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| EC 4
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| University of Florida
|
| Vol #:
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| 1
|
|
|
|
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| EC 5
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| UF
|
| Vol #:
|
| 1
|
|
|
|
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| 2004D-0160
|
| Use of Unapproved Hormone Implants in Veal Calves
|
|
|
|
|
| GDL
1
|
| Guideline
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
|
|
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| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0049
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
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|
|
|
|
|
|
|
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| EC 39
|
| Consultant for Captive Pet Prairie Dog Care
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| Vol #:
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| 1
|
|
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| EC 40
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| Consultant for Captive Pet Prairie Dog Care
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| Vol #:
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| 1
|
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| 2004N-0050
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| Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Dandruff Control Ingredient
|
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| EC 1
|
| Number not used
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| Vol #:
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| 1
|
|
|
|
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| 2004N-0093
|
| Agency Information Collection Activities: Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution , 21 CFR Part 207.
|
|
|
|
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| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
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| 2004N-0115
|
| Prescription Drug Importation Study
|
|
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|
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| EC 15
|
| Blue Cross Blue Shield of North Dakota
|
| Vol #:
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| 1
|
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| EC 16
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| Ms. Anna Ward
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| Vol #:
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| 1
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| EC 17
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| North Dakota State Board of Pharmacy
|
| Vol #:
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| 1
|
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| EMC 5
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| J Shaw
|
| Vol #:
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| 1
|
|
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| LST
3
|
| Detailed Drug Importation Questions
|
| Vol #:
|
| 1
|
|
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|
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| NEC
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
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| 2004N-0133
|
| Part 11, Electronic Record; Electronic Signatures; Public Meeting
|
|
|
|
|
| NM
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
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| 2004P-0164
|
| Exemption from the medical devices tracking requirements for Heartstream automated external defibrillators
|
|
|
|
|
| ACK 1
|
| HFA-305 to Philips Medical Systems
|
| Vol #:
|
| 1
|
|
|
|
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| CP
1
Part 2, 3,
4
|
| Philips Medical Systems
|
| Vol #:
|
| 1
|
|
|
|
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| 2004P-0167
|
| ANADA for a generic equivalent of the innovator products, Garacin (gentamicin sulfate) Pig Pump Oral Solution
|
|
|
|
|
| ACK
1
|
| HFA-305 to First Priority, Inc.
|
| Vol #:
|
| 1
|
|
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| CP
1
|
| First Priority, Inc.
|
| Vol #:
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| 1
|
|
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| 2004P-0168
|
| ANDA Suitability for Glipizide and Metformin Hydrochloride Oral Solution
|
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| ACK 1
|
| HFA-305 to Lachman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
|
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| CP
1
|
| Lachman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
|
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| 2004P-0169
|
| Erroneous Interpretation of the Statutory Definition of the Term "Dietary Supplement"
|
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|
|
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| ACK 1
|
| Coalition To Preserve DSHEA
|
| Vol #:
|
| 1
|
|
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|
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| CP
1
|
| Coalition To Preserve DSHEA
|
| Vol #:
|
| 1
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| 2004Q-0083
|
| Qualified health claim (QHC): Green Tea and Reduced Risk of Cancer
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