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| Dockets Entered
On August 28, 2006
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| Docket #
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| Title
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| 1998N-0359
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| Program priorities/Center for Food Safety & Applied Nutrition
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| 2003E-0256
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| Patent Extension for Ranexa (ranolazine), 4,567,264
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| 2003P-0064
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| Withhold Approval of Generic Lovenox (enoxaparin sodium inje
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| 2003V-0293
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| Laser Light Show
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| 2005D-0202
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| Guidance for Industry on Bar Code Label Requirements; Questions and Answers
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| 2005P-0398
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| ANDA Suitability for Carboplatin Injection, 10 mg/mL in a 1000 mg/100 mL multiple-dose vial
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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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| 2005P-0421
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| To re-evaluate the prescribing information/package insert for new tramdol formulations in light of currently available safety information
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| 2005P-0429
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| re-evaluate the prescribing info/package insert for new tramadol and tramadol as schedule III drugs under the Controlled Substances Act of 1970 as amended
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| 2005P-0430
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| Requests that the Commissioner of Food and Drugs recommend scheduling of tramadol under the Controlled Substances Act.
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| 2005P-0442
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| For patient safety and public health considerations,recommending scheduling tramadol under the Controlled Substances Act
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| 2005P-0463
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| requesting that the Commissioner of Food and Drugs recommend scheduling of tramadol under the Controlled Substances Act
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| 2006E-0033
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| Patent Extension Application for APTIVUS (tipranavir), U.S. Patent No. 5,852,195
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| 2006E-0354
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| Patent Extension Application for VAPRISOL (conivaptan hydrochloride), U.S. Patent No. 5,723,606
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| 2006M-0338
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| P010029 - Nuflexxa (1% Sodium Hyaluronate)
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| 2006M-0339
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| P030019 - ORTHOVISC High Molecular Weight Hyaluronan
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| 2006P-0071
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| 513 (e) Reclassification of Tissue Adhesive For Soft Tissue Approximation
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| 2006P-0096
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| Regarding the following non-binding package requirement for a minimum of - 1/8 inch holes in each package of mushrooms
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| 2006P-0223
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| Switch Plan B and equivalent EC drugs from prescription-only to OTC status without age restrictions, exempt from prescription -dispensing requirement any new drug eligible for filing an ANDA
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| 2006P-0299
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| Determine whether Eloxatin (Oxaliplatin for Injection) 50 mg and 100 mg sterile lyophilized powder vials (NDA #21-492 has been withdrawn for safety or effectiveness reasons
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| 2006V-0269
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| Laser Light Show
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| 2006V-0270
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| Laser Light Show
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| 2006V-0289
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| Laser Light Show
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| 2006V-0304
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| Laser Light Show
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| 1998N-0359
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| Program priorities/Center for Food Safety & Applied Nutrition
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| C 121
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| Juice Products Association (JPA)
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| 9
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| C 122
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| Association for Dressings and Sauces (ADS)
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| 9
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| EC 396
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| Consumer Healthcare Products Association
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| Vol #:
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| 9
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| EC 397
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| AAAAI, ACAAI, & FAAN
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| Vol #:
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| 9
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| 2003E-0256
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| Patent Extension for Ranexa (ranolazine), 4,567,264
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| APP 2
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| Roche Palo Alto LLC
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| Vol #:
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| 1
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| LET 3
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| U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| LET 4
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| U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| LET 5
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| U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2003P-0064
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| Withhold Approval of Generic Lovenox (enoxaparin sodium inje
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| SUP 3
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| sanofi-aventis US LLC
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| Vol #:
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| 6
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| 2003V-0293
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| Laser Light Show
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| VRA 3
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| FDA/CDRH to LumaLaser
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| 1
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| 2005D-0202
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| Guidance for Industry on Bar Code Label Requirements; Questions and Answers
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| EC 4
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| Mr. Dave Lowe
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| Vol #:
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| 2
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| 2005P-0398
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| ANDA Suitability for Carboplatin Injection, 10 mg/mL in a 1000 mg/100 mL multiple-dose vial
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| SUP 1
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| Lachman Consultant Services, Inc.
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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 18076
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| K. Taylor
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| Vol #:
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| 194
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| C 18077
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| C. Heatherington
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| Vol #:
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| 194
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| C 18078
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| C. Hudson
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| Vol #:
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| 194
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| EC 33265
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| Dr. Elaine Adsit
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| Vol #:
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| 195
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| 2005P-0421
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| To re-evaluate the prescribing information/package insert for new tramdol formulations in light of currently available safety information
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| C 1
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| Ortho-McNeil, Inc.
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| Vol #:
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| 2
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| 2005P-0429
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| re-evaluate the prescribing info/package insert for new tramadol and tramadol as schedule III drugs under the Controlled Substances Act of 1970 as amended
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| C 1
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| Ortho-McNeil, Inc.
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| Vol #:
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| 2
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| 2005P-0430
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| Requests that the Commissioner of Food and Drugs recommend scheduling of tramadol under the Controlled Substances Act.
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| C 4
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| Ortho-McNeil, Inc.
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| Vol #:
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| 1
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| 2005P-0442
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| For patient safety and public health considerations,recommending scheduling tramadol under the Controlled Substances Act
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| C 1
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| Ortho-McNeil, Inc.
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| Vol #:
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| 1
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| 2005P-0463
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| requesting that the Commissioner of Food and Drugs recommend scheduling of tramadol under the Controlled Substances Act
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| C 1
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| Ortho-McNeil, Inc.
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| Vol #:
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| 1
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| 2006E-0033
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| Patent Extension Application for APTIVUS (tipranavir), U.S. Patent No. 5,852,195
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| LET 3
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| U.S. Patent and Trademark Office
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| Vol #:
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| 2
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| 2006E-0354
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| Patent Extension Application for VAPRISOL (conivaptan hydrochloride), U.S. Patent No. 5,723,606
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| APP 1
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| Astellas Pharma Inc.
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| Vol #:
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| 1
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| LET 1
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| U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2006M-0338
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| P010029 - Nuflexxa (1% Sodium Hyaluronate)
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| AAV 1
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| Savient Pharmaceuticals, Inc.
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| Vol #:
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| 1
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| 2006M-0339
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| P030019 - ORTHOVISC High Molecular Weight Hyaluronan
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| AAV 1
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| Anika Therapeutics, Inc.
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| Vol #:
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| 1
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| 2006P-0071
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| 513 (e) Reclassification of Tissue Adhesive For Soft Tissue Approximation
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| LET 1
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| FDA/CDRH to Regulatory & Clinical Research Institute, Inc ( RCRI )
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| Vol #:
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| 2
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| 2006P-0096
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| Regarding the following non-binding package requirement for a minimum of - 1/8 inch holes in each package of mushrooms
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| EC 1
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| Mr. Dave Lowe
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| Vol #:
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| 1
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| 2006P-0223
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| Switch Plan B and equivalent EC drugs from prescription-only to OTC status without age restrictions, exempt from prescription -dispensing requirement any new drug eligible for filing an ANDA
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| EC 366
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| Mrs. HEATHER DUNDORE
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| Vol #:
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| 3
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| EC 367
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| Mr. Steve Milam
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| Vol #:
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| 3
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| EC 368
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| Mrs. Jeanette Furman
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| Vol #:
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| 3
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| EC 369
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| Mrs. Patricia Beemer
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| Vol #:
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| 3
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| EC 370
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| Mrs. Nancy Surprenant
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| Vol #:
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| 3
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| EC 371
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| Mr. creed potter
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| Vol #:
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| 3
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| EC 372
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| Mr. Richard DeOrio
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| Vol #:
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| 3
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| EC 373
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| Mr. Steven Miranda
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| Vol #:
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| 3
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| EC 374
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| Mrs. Sunny Calvert
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| Vol #:
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| 3
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| EC 375
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| Ms. Irvia Robles
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| Vol #:
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| 3
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| EC 376
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| Home
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| Vol #:
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| 3
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| EC 377
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| Ms. Patricia Barnes
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| Vol #:
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| 3
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| EC 378
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| Ms. Sheila Schnorr
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| Vol #:
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| 3
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| EC 379
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| Mrs. Paula Ott
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| Vol #:
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| 3
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| EC 380
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| Mrs. Linda Suggs
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| Vol #:
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| 3
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| EC 381
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| Ms. Pamela Ewig
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| Vol #:
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| 3
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| EC 382
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| Mrs. Betty Guth
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| Vol #:
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| 3
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| EC 383
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| Mrs. Donna Lafferty
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| Vol #:
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| 3
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| EC 384
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| Mrs. Teresa Chapman
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| Vol #:
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| 3
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| EC 385
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| Mr. shawn taylor
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| Vol #:
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| 3
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| EC 386
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| Mrs. Marcia Callis-Hellmuth
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| Vol #:
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| 3
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| EC 387
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| Ms. Shana Wells
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| Vol #:
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| 3
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| EC 388
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| Mrs. Danita Scheid
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| Vol #:
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| 3
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| EC 389
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| none
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| Vol #:
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| 3
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| EC 390
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| Mr. Timothy Spoelti
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| Vol #:
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| 3
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