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| Dockets Entered
On June 10, 2005
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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| 2005M-0005
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| PMA BP040046-0 Bio-Rad Laboratories, Multispot HIV-1/HIV-2 Rapid Test
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| 2005P-0008
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| simvastatin tablets 5mg, 10mg, 20mg, and 40 mg
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| 2005P-0046
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| removal of patent listings by reinserting the info in the orange book and maintain the listing until Ranbaxy's term of exclusivity has elapsed
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| 2005P-0225
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| Oxycodone Hydrochloirde Controlled Release Tablets in strengths of 30 mg and 60 mg for ANDA
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| 2005P-0226
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| Declare that Chlorhexidine Gluconate 2% w/v and Isopropyl Alcohol 70% v/v Patient Preoperative Skin Preparation 3mL, is suitable for consideration for consideration as an abbreviated new drug applicat
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
16176
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| Mannatech Incorporated
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| Vol #:
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| 143
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| LET
16177
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| AdvoCare International, L.P.
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| Vol #:
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| 143
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| LET
16178
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| Advocare International, L.P.
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| Vol #:
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| 143
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| LET
16179
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| Enzymatic Therapy
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| Vol #:
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| 143
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| LET
16180
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| Enzymatic Therapy
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| Vol #:
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| 143
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| LET
16181
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| Enzymatic Therapy
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| Vol #:
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| 143
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| LET
16182
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| Enzymatic Therapy
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| Vol #:
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| 143
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| 2005M-0005
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| PMA BP040046-0 Bio-Rad Laboratories, Multispot HIV-1/HIV-2 Rapid Test
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| AAV
1
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| Bio-Rad Laboratories
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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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| 2005P-0008
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| simvastatin tablets 5mg, 10mg, 20mg, and 40 mg
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| C
3
Exhibit
A, B
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| Teva Pharmaceuticals USA
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| Vol #:
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| 1
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| 2005P-0046
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| removal of patent listings by reinserting the info in the orange book and maintain the listing until Ranbaxy's term of exclusivity has elapsed
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| C
1
Exhibit
A, B
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| Teva Pharmaceuticals USA
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| Vol #:
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| 2
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| 2005P-0225
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| Oxycodone Hydrochloirde Controlled Release Tablets in strengths of 30 mg and 60 mg for ANDA
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| ACK
1
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| HFA-305 to The Weinberg Group Inc.
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| Vol #:
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| 1
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| CP
1
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| The Weinberg Group Inc.
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| Vol #:
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| 1
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| 2005P-0226
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| Declare that Chlorhexidine Gluconate 2% w/v and Isopropyl Alcohol 70% v/v Patient Preoperative Skin Preparation 3mL, is suitable for consideration for consideration as an abbreviated new drug applicat
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| ACK
1
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| HFA-305 to Aplicare, Inc
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| Vol #:
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| 1
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| CP
1
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| Aplicare, Inc
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| Vol #:
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| 1
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