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| Dockets Entered
On November 9, 2004
Table of Contents
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| Docket #
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| Title
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| 1997S-0162
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| 30-Day Structure Function
Claim Notification Letters Dietary
|
|
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| 2000D-1392
|
| Guidance for Industry on Botanical
Drug Products
|
|
| 2001P-0075
|
| Switch Status of Emergency
Contraceptives from Rx to OTC
|
|
|
| 2001P-0529
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| Request that '365
Patent Not be Re-listed in Orange Book
|
|
|
| 2004D-0343
|
| Hospital Bed System Dimensional
Guidance to Reduce Entrapment
|
|
| 2004D-0385
|
| Class II Special Controls Guidance
Document: Hepatitis A Serological Assays for the Clinical Laboratory
Diagnosis of Hepatitis A Virus
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| 2004D-0422
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| Guidance for Industry: Animal
Drug Sponsor Fees Under the Animal Drug User Fee Act (ADUFA)
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| 2004D-0443
|
| Guidance for Industry
on Quality Systems Approach to Pharmaceutical Current Good Manufacturing
Regulations
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| 2004N-0330
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| Suicidality in Clinical Trials
for Antidepressant Drugs in Pediatric Patients
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| 2004N-0454
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| Dietary Supplements; Premarket
Notification for New Dietary Ingredient Notifications; Public Meeting
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| 2004P-0074
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| oxandrolone and widely
used anti-coagulant durgs containing the active drug warfarin
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| 2004P-0223
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| Whole Grain Descriptive
Claims
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|
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| 2004P-0235
|
| Request Addition of
Postmarketing Suicide Reports to the Neurontin Labeling
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|
|
| 2004P-0349
|
| Action on Products containing
added Mercury
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|
| 2004P-0472
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| refuse final approval to ANDA
76-258 for a generic fentanyl transdermal lsystem under it current
proposed labeling
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| 2004S-0212
|
| Pandemic Influenza
Preparedness and Response Plan
|
|
|
| 1997S-0162
|
| 30-Day Structure
Function Claim Notification Letters Dietary
|
|
|
| LET
14684
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| Enzymatic Therapy
|
| Vol #:
|
| 128
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|
|
| LET
14685
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| Enzymatic Therapy
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| Vol #:
|
| 128
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|
|
| LET
14686
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| Enzymatic Therapy
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| Vol #:
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| 128
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|
|
| LET
14687
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| Enzymatic Therapy
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| Vol #:
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| 128
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|
|
| LET
14688
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| Enzymatic Therapy
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| Vol #:
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| 128
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|
|
| LET
14689
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| Enzymatic Therapy
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| Vol #:
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| 129
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|
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| LET
14690
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| Enzymatic Therapy
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| Vol #:
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| 129
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|
|
| LET
14691
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| Enzymatic Therapy
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| Vol #:
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| 129
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|
|
| LET
14692
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| Enzymatic Therapy
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| Vol #:
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| 129
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|
|
| LET
14693
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| Enzymatic Therapy
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| Vol #:
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| 129
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|
|
| LET
14694
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| Enzymatic Therapy
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| Vol #:
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| 129
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|
|
| LET
14695
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| Enzymatic Therapy
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| Vol #:
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| 129
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| LET
14696
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| Enzymatic Therapy
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| Vol #:
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| 129
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|
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| LET
14697
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| Enzymatic Therapy
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| Vol #:
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| 129
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|
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| LET
14698
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| Enzymatic Therapy
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| Vol #:
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| 129
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|
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| LET
14699
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| Enzymatic Therapy
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| Vol #:
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| 129
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| LET
14700
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| Enzymatic Therapy
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| Vol #:
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| 129
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|
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| LET
14701
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| Enzymatic Therapy
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| Vol #:
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| 129
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|
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| LET
14702
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| Enzymatic Therapy
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| Vol #:
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| 129
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|
|
| LET
14703
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| Enzymatic Therapy
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| Vol #:
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| 129
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|
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| LET
14704
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| Enzymatic Therapy
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| Vol #:
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| 129
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|
|
| LET
14705
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| Enzymatic Therapy
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| Vol #:
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| 129
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|
|
| LET
14706
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| Enzymatic Therapy
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| Vol #:
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| 129
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|
|
| LET
14707
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| Enzymatic Therapy
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| Vol #:
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| 129
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|
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| LET
14708
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| Enzymatic Therapy
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| Vol #:
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| 129
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|
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| LET
14709
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| Enzymatic Therapy
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| Vol #:
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| 129
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|
| | | | | | | | |
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| LET
14710
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| Herb Pharm
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| Vol #:
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| 129
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| LET
14711
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| Herb Pharm
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| Vol #:
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| 129
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| LET
14712
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| Ashbury Biologicals Inc.
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| Vol #:
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| 129
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| LET
14713
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| Ashbury Biologicals Inc.
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| Vol #:
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| 129
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| LET
14714
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| Adeeva Nutritionals Canada Inc.
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| Vol #:
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| 129
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| LET
14715
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| Perrigo Company of South Carolina
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| Vol #:
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| 129
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| LET
14716
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| Perrigo Company of South Carolina
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| Vol #:
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| 129
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| LET
14717
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| Perrigo Company South Carolina
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| Vol #:
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| 129
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|
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| LET
14718
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| Perrigo Company of South Carolina
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| Vol #:
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| 129
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| LET
14719
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| Perrigo Company of South Carolina
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| Vol #:
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| 129
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| LET
14720
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| Perrigo Company of South Carolina
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| Vol #:
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| 129
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| LET
14721
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| Perrigo Company of South Carolina
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| Vol #:
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| 129
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| LET
14722
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| Perrigo Company of South Carolina
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| Vol #:
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| 129
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| LET
14723
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| Perrigo Company of south Carolina
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| Vol #:
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| 129
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| LET
14724
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| Perrigo Company of South Carolina
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| Vol #:
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| 129
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| LET
14725
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| Perrigo Company of South Carolina
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| Vol #:
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| 129
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| LET
14726
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| Perrigo Company of South Carolina
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| Vol #:
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| 129
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| LET
14727
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| Perrigo Company of South Carolina
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| Vol #:
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| 129
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| LET
14728
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| Perrigo Company of South Carolina
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| Vol #:
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| 129
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| 2000D-1392
|
| Guidance for Industry on Botanical Drug Products
|
|
|
| EC 6
|
| Mrs. CARLENE UPTON
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| Vol #:
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| 1
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
|
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| EC 822
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| Dr. Marla Rowe Gorosh
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| Vol #:
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| 163
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| LET
7
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| HFD-5 to Pharmacists Planning Service, Inc
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| Vol #:
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| 295
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| 2001P-0529
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| Request that '365 Patent Not be Re-listed in Orange Book
|
|
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| LET
1
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| HFD-7 to Rothwell, Figg, Ernst & Manbeck, PC (Mylan Pharmaceuticals Inc)
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| Vol #:
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| 1
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| 2004D-0343
|
| Hospital Bed System Dimensional Guidance to Reduce Entrapment
|
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| EC 8
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| Poudre Valley Hospital
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| Vol #:
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| 1
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| EC 9
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| Mr. James Newton
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| Vol #:
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| 1
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| EC 10
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| Texas Association of Healthcare Facilities Managem
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| Vol #:
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| 1
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| EC 11
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| Valley Regional Medical Center
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| Vol #:
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| 1
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| 2004D-0385
|
| Class II Special Controls Guidance Document: Hepatitis A Serological Assays for the Clinical Laboratory Diagnosis of Hepatitis A Virus
|
|
|
| EC 1
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| Mrs. Sarah Parsons
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| Vol #:
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| 1
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| | | | | | | | |
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| 2004P-0074
|
| oxandrolone and widely used anti-coagulant durgs containing the active drug warfarin
|
|
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| SUP
2
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| Savient Pharmaceuticals
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| Vol #:
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| 1
|
|
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| 2004P-0223
|
| Whole Grain Descriptive Claims
|
|
|
| LET
1
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| HFS-800 to Patton Bogas LLP
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| Vol #:
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| 1
|
|
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| 2004P-0235
|
| Request Addition of Postmarketing Suicide Reports to the Neurontin Labeling
|
|
|
| LET
1
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| HFD-5 to Finkelstein and Partners
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| Vol #:
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| 1
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| 2004P-0349
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| Action on Products containing added Mercury
|
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| EC
21
Attachment
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| Autism Healing Network
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| Vol #:
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| 1
|
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| 2004P-0472
|
| refuse final approval to ANDA 76-258 for a generic fentanyl transdermal lsystem under it current proposed labeling
|
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| C
1
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| Drug Free America Foundation, Inc.
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| Vol #:
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| 1
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| 2004S-0212
|
| Pandemic Influenza Preparedness and Response Plan
|
|
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| EC
19
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| Tennessee Department of Health
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| Vol #:
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| 1
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| EC
20
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| GlaxoSmithKline
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| Vol #:
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| 1
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| EC 21
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| Dr. Merritt Schreiber
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| Vol #:
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| 1
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| EC 22
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| Dr. Merritt Schreiber
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| Vol #:
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| 1
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| EC
23
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| Idaho Department of Health and Welfare
|
| Vol #:
|
| 1
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| EC
24
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| Quidel Corporation
|
| Vol #:
|
| 1
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