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| Dockets Entered
On March 9, 2006
Table of Contents
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| Docket #
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| Title
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| 2000D-1598
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| Voluntary Labeling for Bioengineered Foods
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| 2004P-0329
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| Request Public Hearings regarding the sales, distribution and use of hand-held Doppler fetoscopes
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| 2005D-0286
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| Draft Guidance for Industry on INDs Approaches to Complying with CGMP During Phase 1; Availability
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| 2005D-0330
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| Guidance for Industry and FDA Review Staff on Collection of Platelets by Automated Methods
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| 2005D-0438
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| Guidance for Industry on Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency
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| 2005D-0481
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| Guidance for Industry, Lead in Candy Likely To Be Consumed Frequently by Small Children: Recommended Maximum Level and Enforcement Policy, Availability; and draft supporting document, Supporting Do
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| 2005FL-0488
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| Food Allergen Labeling Notification (FALN): Starter Growth Media, Soy
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| 2005N-0354
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| Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
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| 2005N-0374
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| Use of Ozone-Depleting Substance: Essential-Use Determination of Over the Counter Epinephrine Metered-Dose Inhalers
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| 2005P-0121
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| Non-invasive Bone Growth Stimulator be reclassified from Class III to Class II
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| 2005P-0224
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| To request administrative action regarding the purported weight and fat loss benefits of dairy products
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| 2005P-0242
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| ANDA for a sterile Vancomycin Hydrochloirde,USP bulk package in 100 gram dosage strength in plasti bags
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| 2005P-0305
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| Remove Dietary Supplements that Contain the Drug Pyridoxamine
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| 2005P-0352
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| bioequivalence criteria be applied separately to oxybutynin and its active metabolite, desethyloxbutynin
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| 2005P-0358
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| Determine that sponsors of human drug applications for positron emission tomography (PET) drug be exempt from paying certain user fees assessed pursuant to the prescription drug.
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| 2005P-0360
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| salmon calcitonin products unless certain conditions are met FDA should not approved
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| 2005P-0377
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| Petition to Rescind the "Generally Recognized as Safe" or GRAS Status for Aluminum Based Food Additives
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| 2005P-0383
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| refuse to approve any ANDA for generic oral products containing oxandrolone until the expiration od that exclusitity peroid on June 20, 2008.
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| 2005P-0436
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| ADA 21-863' Ibuprogen Liquid filled gelatin capsules 200 mg; Ranbaxy Laboratories, Ltd.
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| 2005P-0456
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| Determine that the discontinued formulation Zosyn (piperacillin and tazobactam for injection), was not discontinued for safety and efficacy reasons
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| 2005P-0458
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| Refrain from approving ANDA 77-271 until the three-year period of market exclusivity for the product has expired.
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| 2005P-0459
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| To enforce ban on carbon monoxide gas in fresh meat packaging
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| 2005V-0489
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| Laser Light Show
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| 2006E-0050
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| Patent Extension Application for BYETTA (exenatide injection), U.S. Patent No. 5,424,286
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| 2006F-0059
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| Safe Use of Polydextrose as a Bulking Agent, Formulation Aid, Humectant and Texturizer in All Foods, except Meat and Poultry (FAP 6A4763)
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| 2006FL-0017
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| Food Allergen Labeling Notification for Purity Foods Vita Spelt
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| 2006P-0052
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| Determine whether Sustiva (efavirenz) Tablets, 300 mg (NDA 21-360), has been voluntarily withdrawn for safety or effectiveness reasons
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| 2006P-0084
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| ANDA Suitability for 1.25 mg, 2.50 mg, 5 mg, and 10 mg Ramipril Tablets
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| 2006P-0090
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| Immediately begin the phased removal from the market of propoxyphene (Darvon) and all propoxyphene-containing products.
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| 2006P-0102
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| Take appropriate remedial action relating to an apparent safety issue regarding Bellatal ER
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| 2000D-1598
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| Voluntary Labeling for Bioengineered Foods
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| C 10012
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| B. Stewart
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| Vol #:
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| 580
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| C 10013
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| K. Yoder
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| Vol #:
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| 580
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| 2004P-0329
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| Request Public Hearings regarding the sales, distribution and use of hand-held Doppler fetoscopes
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| C 1
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| M. Varner, MD
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| Vol #:
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| 1
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| C 2
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| The BABYDATER Company
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| Vol #:
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| 2
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| 2005D-0286
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| Draft Guidance for Industry on INDs Approaches to Complying with CGMP During Phase 1; Availability
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| C
1
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| Elemental Research, Inc.
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| Vol #:
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| 1
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| 2005D-0330
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| Guidance for Industry and FDA Review Staff on Collection of Platelets by Automated Methods
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| C 49
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| B. Robinson
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| Vol #:
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| 6
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| C 50
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| H. Leonard
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| Vol #:
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| 6
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| 2005D-0438
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| Guidance for Industry on Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency
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| C
1
Attachment
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| Plasma Protein Therapeutics Association (PPTA)
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| Vol #:
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| 1
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| 2005D-0481
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| Guidance for Industry, Lead in Candy Likely To Be Consumed Frequently by Small Children: Recommended Maximum Level and Enforcement Policy, Availability; and draft supporting document, Supporting Do
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| C
2
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| Baltimore City Health Department
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| Vol #:
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| 1
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| C
3
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| Toxixs in Packaging Clearinghouse (tpch)
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| Vol #:
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| 1
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| C 4
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| New York City Department of Health and Mental hygiene (NYC DOHMH)
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| Vol #:
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| 1
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| 2005FL-0488
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| Food Allergen Labeling Notification (FALN): Starter Growth Media, Soy
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| PDN
1
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| HF-21 to F & A Dairy of California Inc
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| Vol #:
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| 1
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| 2005N-0354
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| Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
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| C
12
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| American Association of Orthopaedic Surgeons (AAOS/Academy)
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| Vol #:
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| 15
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| C
13
Attachment
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| Contact Lens Institute (CLI)
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| Vol #:
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| 15
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| C
14
Attachment
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| Advanced Medical Technology Association (AdvaMed)
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| Vol #:
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| 15
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| C
15
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| Emdeon Corporation (Emdeon)
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| Vol #:
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| 15
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| C
16
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| Eli Lilly and Company (Lilly)
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| Vol #:
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| 15
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| 2005N-0374
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| Use of Ozone-Depleting Substance: Essential-Use Determination of Over the Counter Epinephrine Metered-Dose Inhalers
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| C 9
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| Eligible
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| Vol #:
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| 1
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| C 10
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| S. Weintraub
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| Vol #:
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| 1
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| LET 1
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| HFD-240 to S. Weintraub
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| Vol #:
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| 1
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| 2005P-0121
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| Non-invasive Bone Growth Stimulator be reclassified from Class III to Class II
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| C
11
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| BGS Reclassification Opposition Group (BGS Group)
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| Vol #:
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| 3
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| 2005P-0224
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| To request administrative action regarding the purported weight and fat loss benefits of dairy products
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| C 1
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| D. Lowe
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| Vol #:
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| 2
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| 2005P-0242
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| ANDA for a sterile Vancomycin Hydrochloirde,USP bulk package in 100 gram dosage strength in plasti bags
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| C 1
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| D. Lowe
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| Vol #:
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| 1
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| 2005P-0305
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| Remove Dietary Supplements that Contain the Drug Pyridoxamine
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| M
1
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| Council for Responsible Nutrition (CRN)
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| Vol #:
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| 1
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| 2005P-0352
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| bioequivalence criteria be applied separately to oxybutynin and its active metabolite, desethyloxbutynin
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| LET
1
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| HFD-005 to Ortho-McNeil Pharmaceutical, Inc.
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| Vol #:
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| 2
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| 2005P-0358
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| Determine that sponsors of human drug applications for positron emission tomography (PET) drug be exempt from paying certain user fees assessed pursuant to the prescription drug.
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| LET
1
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| HFD-005 to Hyman, Phelps & McNamara, P.C
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| Vol #:
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| 1
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| 2005P-0360
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| salmon calcitonin products unless certain conditions are met FDA should not approved
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| LET
1
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| HFD-005 to Foley & Lardner LLP
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| Vol #:
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| 1
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| 2005P-0377
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| Petition to Rescind the "Generally Recognized as Safe" or GRAS Status for Aluminum Based Food Additives
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| SUP
7
References
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| Department of the Planet Earth
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| Vol #:
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| 4
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| 2005P-0383
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| refuse to approve any ANDA for generic oral products containing oxandrolone until the expiration od that exclusitity peroid on June 20, 2008.
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| C
3
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| Frommer Lawrence & Haug, LLP
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| Vol #:
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| 1
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| 2005P-0436
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| ADA 21-863' Ibuprogen Liquid filled gelatin capsules 200 mg; Ranbaxy Laboratories, Ltd.
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| LET
1
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| Banner Pharmacaps Inc.
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| Vol #:
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| 1
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| 2005P-0456
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| Determine that the discontinued formulation Zosyn (piperacillin and tazobactam for injection), was not discontinued for safety and efficacy reasons
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| SUP
1
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| Sandoz Inc.
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| Vol #:
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| 2
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| 2005P-0458
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| Refrain from approving ANDA 77-271 until the three-year period of market exclusivity for the product has expired.
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| RC
1
References
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| Medi-Flex, Inc.
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| Vol #:
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| 1
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| 2005P-0459
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| To enforce ban on carbon monoxide gas in fresh meat packaging
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| C
4
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| Pactiv Corporation
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| Vol #:
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| 3
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| 2005V-0489
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| Laser Light Show
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| VRA
1
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| HFZ-200 to Fullhouse Productions L.L.C.
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| Vol #:
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| 1
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| 2006E-0050
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| Patent Extension Application for BYETTA (exenatide injection), U.S. Patent No. 5,424,286
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| |
|
|
| C 1
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| D. Lowe
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| Vol #:
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| 1
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| 2006F-0059
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| Safe Use of Polydextrose as a Bulking Agent, Formulation Aid, Humectant and Texturizer in All Foods, except Meat and Poultry (FAP 6A4763)
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|
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| C
1
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| Calorie Control Council
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| Vol #:
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| 1
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| 2006FL-0017
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| Food Allergen Labeling Notification for Purity Foods Vita Spelt
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| C 1
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| L. Peppas
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| Vol #:
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| 1
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| 2006P-0052
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| Determine whether Sustiva (efavirenz) Tablets, 300 mg (NDA 21-360), has been voluntarily withdrawn for safety or effectiveness reasons
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| C 1
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| D. Lowe
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| Vol #:
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| 1
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| 2006P-0084
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| ANDA Suitability for 1.25 mg, 2.50 mg, 5 mg, and 10 mg Ramipril Tablets
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| C
1
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| Hyman, Phelps & McNamara, P.C.
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| Vol #:
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| 1
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| 2006P-0090
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| Immediately begin the phased removal from the market of propoxyphene (Darvon) and all propoxyphene-containing products.
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|
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| LET
1
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| Hunton & Williams
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| Vol #:
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| 1
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| 2006P-0102
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| Take appropriate remedial action relating to an apparent safety issue regarding Bellatal ER
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| ACK
1
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| HFA-305 to Lord Bissell Brook
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| Vol #:
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| 1
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| CP
1
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| Lord Bissell Brook
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| Vol #:
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| 1
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