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| Dockets Entered
On July 24, 2007
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| Docket #
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| Title
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| 1977N-0240
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| Single-Entity Coronary Vasodilators
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| 1994F-0008
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| Safe use Machine Source High Energy X-Rays
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| 2001E-0095
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| da Vinci System, Patent Extension Application No.5,808,665
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| 2005N-0349
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| FDA Survey of Current Manufacturing Practices in the Food Industry
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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| 2006N-0036
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Possible Footnotes and Cueing Schemes to Help Consumers Interpret Quantitative Trans Fat Disclosur
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| 2006N-0037
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Trans Fat Claims on Foods
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| 2006N-0527
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Threshold of Regulation for Substances Used in Food-Contact Articles
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| 2007E-0144
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| Patent Extension Application for VEREGEN, also known as POLYPHENON E, (kunecatechins) Ointment 15%, U.S. Patent No. 5,968,973
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| 2007E-0145
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| Patent Extension Application for INVEGA (paliperidone), U.S. Patent No. 5,518,952
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| 2007E-0146
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| Patent Extension Application for LUCENTIS (ranibizumab), U.S. Patent No. 7,060,269
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| 2007E-0176
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| Patent Extension Application for VEREGEN, also known as POLYPHENON E (kunecatechins) Ointment 15%, U.S. Patent No. 5,795,911
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| 2007E-0184
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| Patent Extension Application for Avastin (bevacizumab), U.S. Patent No. 6,639,055
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| 2007N-0105
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Mental Models Study of Food Bioterrorism Risk Awareness
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| 2007N-0279
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Color Additive Certification Requests and Recordkeeping
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| 2007P-0004
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| Take steps to insure the safety of Americans regarding the misuses of Lasik
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| 2007P-0052
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| Determine whether a Reference Listed drug Brethine has been voluntarily withdrawn from distribution and sale for reasons other than safety or effectiveness, and thus permit the filing of an ANDA for B
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| 2007P-0295
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| Make a determination that Inderal (Propranolol Hydrochloride Tablets, 10 mg and 20 mg, NDA 016418, Product Numbers 001 and 003 respectively) held by Wyeth Pharmaceuticals, Inc., were not discontinued
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| 1977N-0240
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| Single-Entity Coronary Vasodilators
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| WDL 10
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| Hercon Laboratories Corporation
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| Vol #:
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| 32
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| 1994F-0008
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| Safe use Machine Source High Energy X-Rays
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| ND 1
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| FDA
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| Vol #:
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| 1
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| 2001E-0095
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| da Vinci System, Patent Extension Application No.5,808,665
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| LET 5
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2005N-0349
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| FDA Survey of Current Manufacturing Practices in the Food Industry
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| NEC 1
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| FDA
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| Vol #:
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| 1
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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| C 18329
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| D. Albus
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| Vol #:
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| 198
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| C 18330
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| A. Kistler
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| Vol #:
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| 198
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| 2006N-0036
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Possible Footnotes and Cueing Schemes to Help Consumers Interpret Quantitative Trans Fat Disclosur
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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
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| FDA
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| Vol #:
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| 1
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| 2006N-0037
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Trans Fat Claims on Foods
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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
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| FDA
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| Vol #:
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| 1
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| 2006N-0527
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Threshold of Regulation for Substances Used in Food-Contact Articles
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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
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| FDA
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| Vol #:
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| 1
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| 2007E-0144
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| Patent Extension Application for VEREGEN, also known as POLYPHENON E, (kunecatechins) Ointment 15%, U.S. Patent No. 5,968,973
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| LET 2
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2007E-0145
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| Patent Extension Application for INVEGA (paliperidone), U.S. Patent No. 5,518,952
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| LET 2
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2007E-0146
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| Patent Extension Application for LUCENTIS (ranibizumab), U.S. Patent No. 7,060,269
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| LET 2
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2007E-0176
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| Patent Extension Application for VEREGEN, also known as POLYPHENON E (kunecatechins) Ointment 15%, U.S. Patent No. 5,795,911
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| LET 2
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2007E-0184
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| Patent Extension Application for Avastin (bevacizumab), U.S. Patent No. 6,639,055
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| LET 2
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2007N-0105
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Mental Models Study of Food Bioterrorism Risk Awareness
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| N 2
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| FDA
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| Vol #:
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| 1
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| 2007N-0279
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Color Additive Certification Requests and Recordkeeping
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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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| 2007P-0004
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| Take steps to insure the safety of Americans regarding the misuses of Lasik
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| PDN 1
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| FDA/CDRH
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| Vol #:
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| 1
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| 2007P-0052
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| Determine whether a Reference Listed drug Brethine has been voluntarily withdrawn from distribution and sale for reasons other than safety or effectiveness, and thus permit the filing of an ANDA for B
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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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| 2007P-0295
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| Make a determination that Inderal (Propranolol Hydrochloride Tablets, 10 mg and 20 mg, NDA 016418, Product Numbers 001 and 003 respectively) held by Wyeth Pharmaceuticals, Inc., were not discontinued
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| ACK 1
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| FDA/DDM to Regulus Pharmaceutical Consulting, Inc.
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| Vol #:
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| 1
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| CP 1
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| Regulus Pharmaceutical Consulting, Inc.
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| Vol #:
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| 1
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