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| Dockets Entered
On March 19, 2004
Table of Contents
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| Docket #
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| Title
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| 1980N-0208
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| BIOLOGICAL PRODUCTS; BACTERIAL VACCINES AND TOXIODS
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| 1992N-0297
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| Prescription Drug Marketing Act of 1987, Drug Amds of 1992
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 1998N-1111
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| External Penile Rigidity Devices;Proposed Classification
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| 2004D-0071
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| Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: External Penile Rigidity Devices
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| 2004D-0124
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| Guidance for Industry: Animal Drug User Fees and Fee Waivers and Reductions
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| 2004N-0114
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Institutional Review Boards--Part 56 (21 CFR Part 56.115)
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| 2004N-0115
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| Prescription Drug Importation Study
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| 2004P-0129
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| Modify Current Regulation Governing Structure/function Claims, 21 CFR Pt. 101.93
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| 2004P-0136
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| ANADA Suitability Petition for Florfenicol Injectable Solution
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| 2004P-0139
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| approval of generic versions of Concerta (methylphenidate HCI extended-release tablets are both bioequivalent and clinically equivalent to the innovator product
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| 2004P-0140
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| Rescind the March 1, 2004 Dear Applicant Letter Regarding Metaxalone Labeling
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| 2004Q-0098
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| Qualified Health Claim: Calcium and hypertension
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| 2004Q-0099
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| Qualified Health Claim: Calcium and menstrual disorders
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| 2004V-0094
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| Laser Light Show
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| 2004V-0135
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| Laser Light Show
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| 2004V-0137
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| Laser Light Show
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| 2004V-0138
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| Laser Light Show
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| 1980N-0208
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| BIOLOGICAL PRODUCTS; BACTERIAL VACCINES AND TOXIODS
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| REF
1
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| References
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| Vol #:
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| 126
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| 1992N-0297
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| Prescription Drug Marketing Act of 1987, Drug Amds of 1992
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| NFR
4
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| FDA
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| Vol #:
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| 8
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
13324
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| DMD Pharmaceuticals
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| Vol #:
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| 110
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| LET
13325
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| Pharmavite LLC
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| Vol #:
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| 110
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| LET
13326
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| Enzymatic Therapy Natural Medicines
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| Vol #:
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| 110
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| LET
13327
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| Enzymatic Therapy Natural Medicines
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| Vol #:
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| 110
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| LET
13328
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| Enzymatic Therapy Natural Medicines
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| Vol #:
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| 110
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| LET
13329
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| Enzymatic Therapy Natural Medicines
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| Vol #:
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| 110
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| LET
13330
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| Enzymatic Therapy Natural Medicines
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| Vol #:
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| 110
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| LET
13331
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| Enzymatic Therapy Natural Medicines
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| Vol #:
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| 110
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| LET
13332
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| PhytoPharmicak Natural Medicines
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| Vol #:
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| 110
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| LET
13333
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| PhytoPharmica Natural Medicines
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| Vol #:
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| 110
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| | | | | | | | |
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| EMC 4897
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| H. Gaims
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| Vol #:
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| 169
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| EMC 4898
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| J. Ruvel
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| Vol #:
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| 169
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| EMC 4899
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| M. O'Connor
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| Vol #:
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| 169
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| EMC 4900
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| S. Safadi
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| Vol #:
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| 169
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| 2004D-0071
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| Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: External Penile Rigidity Devices
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| GDL
1
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| Guideline
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| Vol #:
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| 1
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| NAD
1
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| FDA
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| Vol #:
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| 1
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| 2004D-0124
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| Guidance for Industry: Animal Drug User Fees and Fee Waivers and Reductions
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| GDL
1
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| Guideline
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| Vol #:
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| 1
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| NAD
1
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| FDA
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| Vol #:
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| 1
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| 2004N-0114
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Institutional Review Boards--Part 56 (21 CFR Part 56.115)
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| N
1
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| FDA
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| Vol #:
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| 1
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| 2004N-0115
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| Prescription Drug Importation Study
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| NM
2
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| FDA
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| Vol #:
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| 1
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| 2004P-0129
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| Modify Current Regulation Governing Structure/function Claims, 21 CFR Pt. 101.93
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| CR
1
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| American Longevity Inc
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| Vol #:
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| 1
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| 2004P-0136
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| ANADA Suitability Petition for Florfenicol Injectable Solution
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| ACK 1
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| HFA-305 to Intervet, Inc.
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| Vol #:
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| 1
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| CP
1
Generic Labeling
Pioneer Labeling
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| Intervet, Inc.
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| Vol #:
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| 1
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| 2004P-0139
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| approval of generic versions of Concerta (methylphenidate HCI extended-release tablets are both bioequivalent and clinically equivalent to the innovator product
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| ACK 1
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| HFA-305 to McNeil Consymer & Specialty Pharmaceuticals
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| Vol #:
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| 1
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| ACK 2
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| Number not used
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| Vol #:
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| 1
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| CP
1
References
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| McNeil Consumer & Specialty Pharmaceuticals
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| Vol #:
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| 1
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| 2004P-0140
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| Rescind the March 1, 2004 Dear Applicant Letter Regarding Metaxalone Labeling
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| ACK 1
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| HFA-305 to King Pharmaceuticals, Inc.
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| Vol #:
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| 1
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| ACK 2
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| HFA-305 to King Pharmaceuticals, Inc.
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| Vol #:
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| 1
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| CP
1
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| King Pharmaceuticals, Inc.
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| Vol #:
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| 1
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| PSA
1
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| King Pharmaceuticals, Inc.
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| Vol #:
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| 1
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| 2004Q-0098
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| Qualified Health Claim: Calcium and hypertension
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| ACK
2
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| HFS-200 to Emord and Associates PC
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| Vol #:
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| 9
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| 2004Q-0099
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| Qualified Health Claim: Calcium and menstrual disorders
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