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| Dockets Entered
On February 9, 2004
Table of Contents
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| Docket #
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| Title
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| 1996D-0041
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| Clinical Safety Data Management: Safety Update Reports
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| |
|
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| 1997N-0484R
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| Human Cellular and Tissue-Based Products
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| |
|
|
| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| |
|
|
| 1998F-0716
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| Laminate Structures for Use at 250 Degrees & Above
|
| |
|
|
| 2004D-0041
|
| Guidance for Industry on Providing Regulatory Submissions in Electronic Format--Content of Labeling
|
| |
|
|
| 2004P-0051
|
| Dyclone (dyclonine hydrochloride) Topical Solution 0.5% and 1.0% (NDA 9-925) was voluntarily withdrawn or withheld from sale for reasons other then safety or efficacy
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| |
|
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| 2004P-0058
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| market phenylbutazone powder that is the same formulation as the approved NADA Butatron(phenylbutazone) tablets
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| |
|
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| 2004V-0057
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| Laser Light Show
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| |
|
|
| 1996D-0009
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| Impurities in new drug products guideline
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| |
|
|
| EC 1
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| Di Gregorio, Carl
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| Vol #:
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| 1
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| |
|
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| 1996D-0041
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| Clinical Safety Data Management: Safety Update Reports
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| |
|
|
| GDL
2
|
| Guideline
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| Vol #:
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| 1
|
| |
|
|
| NAD
4
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| FDA
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| Vol #:
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| 1
|
| |
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| 1997N-0484R
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| Human Cellular and Tissue-Based Products
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| |
|
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| NCR
1
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| FDA
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| Vol #:
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| 7
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| |
|
|
| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| |
|
|
| LET
12600
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| NBTY Inc.
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| Vol #:
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| 102
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| |
|
|
| LET
12601
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| NBTY Inc.
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| Vol #:
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| 102
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| |
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| LET
12602
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| NBTY Inc.
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| Vol #:
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| 102
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| |
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| LET
12603
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| NBTY Inc.
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| Vol #:
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| 102
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| |
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| LET
12604
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| NBTY Inc.
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| Vol #:
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| 102
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| |
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| LET
12605
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| NBTY Inc.
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| Vol #:
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| 102
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| |
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| LET
12606
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| NBTY Inc.
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| Vol #:
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| 102
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| |
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| LET
12607
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| NBTY Inc.
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| Vol #:
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| 102
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| |
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|
| LET
12608
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| NBTY Inc.
|
| Vol #:
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| 102
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| |
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| LET
12609
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| NBTY Inc.
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| Vol #:
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| 102
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| |
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| LET
12610
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| NBTY Inc.
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| Vol #:
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| 102
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| |
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| LET
12611
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| NBTY Inc.
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| Vol #:
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| 102
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| |
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| LET
12612
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| NBTY Inc.
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| Vol #:
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| 102
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| |
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| LET
12613
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| NBTY Inc.
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| Vol #:
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| 102
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| |
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| LET
12614
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| NBTY Inc.
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| Vol #:
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| 102
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| |
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| LET
12615
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| NBTY Inc.
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| Vol #:
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| 102
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| |
|
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| LET
12616
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| NBTY Inc.
|
| Vol #:
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| 102
|
|
| | | | | | | | |
| |
|
|
| LET
12617
|
| NBTY Inc.
|
| Vol #:
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| 102
|
| |
|
|
| LET
12618
|
| NBTY Inc.
|
| Vol #:
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| 102
|
| |
|
|
| LET
12619
|
| NBTY Inc.
|
| Vol #:
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| 102
|
| |
|
|
| LET
12620
|
| NBTY Inc.
|
| Vol #:
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| 102
|
| |
|
|
| LET
12621
|
| NBTY Inc.
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| Vol #:
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| 102
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| |
|
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| LET
12622
|
| NBTY Inc.
|
| Vol #:
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| 102
|
| |
|
|
| LET
12623
|
| NBTY Inc.
|
| Vol #:
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| 102
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| |
|
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| LET
12624
|
| NBTY Inc.
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| Vol #:
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| 102
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| |
|
|
| LET
12625
|
| NBTY Inc.
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| Vol #:
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| 102
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| |
|
|
| LET
12626
|
| NBTY Inc.
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| Vol #:
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| 102
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| |
|
|
| LET
12627
|
| NBTY Inc.
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| Vol #:
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| 102
|
| |
|
|
| LET
12628
|
| NBTY Inc.
|
| Vol #:
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| 102
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| |
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| LET
12629
|
| NBTY Inc.
|
| Vol #:
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| 102
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| |
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|
| LET
12630
|
| NBTY Inc.
|
| Vol #:
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| 103
|
| |
|
|
| LET
12631
|
| NBTY Inc.
|
| Vol #:
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| 103
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| |
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| LET
12632
|
| NBTY Inc.
|
| Vol #:
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| 103
|
| |
|
|
| 1998D-0173
|
| PMA/510(K)Expedited Review Guidance for Industry
|
| |
|
|
| EC 1
|
| sang songhua, sang songhua
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| Vol #:
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| 1
|
| |
|
|
| EC 2
|
| LUCAS RAMIREZ, FELIPE
|
| Vol #:
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| 1
|
| |
|
|
| 1998F-0716
|
| Laminate Structures for Use at 250 Degrees & Above
|
| |
|
|
| NWL
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 1999D-1938
|
| Development of Generic Drug Products
|
| |
|
|
| EC 4
|
| Ali, Obaid
|
| Vol #:
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| 1
|
| |
|
|
| 2000P-0685
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| Revise of Yogurt Standards
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| |
|
|
| EC 11
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| Beausire, Robert
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| Vol #:
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| 2
|
| |
|
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| EC 12
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| Ouellette, Andre
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| Vol #:
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| 2
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| |
|
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| EC 13
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| de Cardenas, Gilbert
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| Vol #:
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| 2
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| |
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| EC 14
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| Hyland, Katie
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| Vol #:
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| 2
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| |
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| EC 15
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| Clemens, Roger
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| Vol #:
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| 2
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| |
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| EC 16
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| Caradec, Philippe
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| Vol #:
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| 2
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| |
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| EC 17
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| Well, Brett
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| Vol #:
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| 2
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| |
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| EC 18
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| Gordon, Jeffrey
|
| Vol #:
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| 2
|
| |
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| 2002D-0428
|
| Information for the use of Human Blood & Blood Components
|
| |
|
|
| EC 1
|
| cunningham, john
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| Vol #:
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| 1
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|
| | | | | | | | |
| |
|
|
| 2002N-0276
|
| Bioterrorism Preparedness; Registration of Food Facilities
|
| |
|
|
| EC 347
|
| Badanin, Yury
|
| Vol #:
|
| 20
|
| |
|
|
| 2002N-0278
|
| Bioterrorism; Prior Notice of Imported Food Shipments
|
| |
|
|
| EC 382
|
| Boyer, Scott
|
| Vol #:
|
| 22
|
| |
|
|
| EC 383
|
| Yang, Song
|
| Vol #:
|
| 22
|
| |
|
|
| 2003D-0476
|
| Guidance for Industry on Product Recalls, Including Removals and Corrections; Availability
|
| |
|
|
| EC 2
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| Van Duyne, Ann
|
| Vol #:
|
| 1
|
| |
|
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| EC 3
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| oneill, Susan
|
| Vol #:
|
| 1
|
| |
|
|
| 2003D-0498
|
| Compliance Program Guidance Manual 7371.009; BSE/Ruminant Feed Ban Inspections; Availability
|
| |
|
|
| EC 1
|
| Combs, Claudia
|
| Vol #:
|
| 1
|
| |
|
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| EC 2
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| Radford, Nancy
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| Vol #:
|
| 1
|
| |
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| EC 3
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| Stotts, Denise
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| Vol #:
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| 1
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|
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| EC 4
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| McMillan, M.N.
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| Vol #:
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| 1
|
| |
|
|
| 2003D-0522
|
| Draft Guidance for Industry and FDA Staff; Premarket Submissions and Labeling Recommendations for Drugs of Abuse Screening Tests; Availability
|
| |
|
|
| EC 1
|
| Sasse, Edward
|
| Vol #:
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| 1
|
| |
|
|
| 2003D-0558
|
| Guidance Levels for Radionuclides in Domestic and Imported Foods
|
| |
|
|
| EC 1
|
| Porterfield, Donivan
|
| Vol #:
|
| 1
|
| |
|
|
| 2003N-0400
|
| Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
|
| |
|
|
| EC 442
|
| Williams, Jean
|
| Vol #:
|
| 10
|
| |
|
|
| 2003N-0528
|
| Revision of the Requirements for Spore-Forming Microorganisms
|
| |
|
|
| EC 1
|
| Ragosta, Annette
|
| Vol #:
|
| 1
|
| |
|
|
| 2003N-0529
|
| Amending the MedWatch Forms to Collect Postmarketing Adverse Event Data Relating to Race and Ethnicity
|
| |
|
|
| EC 1
|
| George, Elisabeth
|
| Vol #:
|
| 1
|
| |
|
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| EC 2
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| Goulding, Barbara
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0555
|
| Maintain the Electroconvulsive Therapy Device in Class III for All Indications
|
| |
|
|
| EC 1
|
| Penney, Darby
|
| Vol #:
|
| 1
|
| |
|
|
| EC 2
|
| jimenez, raul e
|
| Vol #:
|
| 1
|
| |
|
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| EC 3
|
| Heath, Christina
|
| Vol #:
|
| 1
|
| |
|
|
| EC 4
|
| ebert, george
|
| Vol #:
|
| 1
|
| |
|
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| EC 5
|
| Ducker, W. Marc
|
| Vol #:
|
| 1
|
| |
|
|
| EC 6
|
| Hill, Kathleen (Katie) M.
|
| Vol #:
|
| 1
|
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|
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| EC 7
|
| Child, Beckie
|
| Vol #:
|
| 1
|
| |
|
|
| EC 8
|
| Rossetti, Cynthia
|
| Vol #:
|
| 1
|
| |
|
|
| 2003Q-0559
|
| Qualified Health Claim: Monounsaturated fatty acids and reduced risk of coronary heart disease
|
| |
|
|
| EC 1
|
| Profaci, John
|
| Vol #:
|
| 5
|
| |
|
|
| 2004D-0041
|
| Guidance for Industry on Providing Regulatory Submissions in Electronic Format--Content of Labeling
|
| |
|
|
| GDL
1
|
| Guideline
|
| Vol #:
|
| 1
|
| |
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0051
|
| Dyclone (dyclonine hydrochloride) Topical Solution 0.5% and 1.0% (NDA 9-925) was voluntarily withdrawn or withheld from sale for reasons other then safety or efficacy
|
| |
|
|
| ACK
1
|
| HFA-305 to Arent Fox Kintner Plotkin & Kahn PLLC
|
| Vol #:
|
| 1
|
| |
|
|
| CP
1
|
| Arent Fox,Kintner Plotkin & Kahn PLLC
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0058
|
| market phenylbutazone powder that is the same formulation as the approved NADA Butatron(phenylbutazone) tablets
|
| |
|
|
| ACK
1
|
| HFA-305 to Bimeda A Division of Cross Vetpharm Group
|
| Vol #:
|
| 1
|
| |
|
|
| CP
1
|
| Bimeda A Divisio of Cross Group
|
| Vol #:
|
| 1
|
| |
|
|
| 2004V-0057
|
| Laser Light Show
|
| |
|
|
| ACK
1
|
| HFA-305 to Entertainment USA of Tn. DBA Platinum Pluus
|
| Vol #:
|
| 1
|
| |
|
|
| VAR
1
|
| Entertainment USA of Tn DBA Platinum Plus
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| Vol #:
|
| 1
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