Dockets Entered on March 16, 2006

Dockets Management



Dockets Entered On March 16, 2006 Table of Contents



Docket #	Title

2005P-0411	Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs

2006FL-0120	Food Allergency Labeling Notification (FALN): Anyhydrous Lactitol and Lactitol Monohydrate

2006P-0114	Refrain from taking administrative action regarding approval and/or effective date of final approval of any and all ANDAs for a generic version of Metrogel-Vaginal 0.75%

2006P-0117	Declare that Omeprazole Tablets, 20 mg (proposed formulation), is suitable for submission aas an ANDA

2006P-0120	Enforce ban on carbon monoxide in the packaging of fresh tuna and fresh tuna that is subsequently frozen

2006V-0119	Laser Light Show

2005P-0411	Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
C 2820	M. Mason	Vol #:	59

C 2821	M. Bopent	Vol #:	59

C 2822	H. Abend	Vol #:	59

C 2823	E. Brunbaker	Vol #:	59

C 2824	B. Helriegel	Vol #:	59

C 2825	M. Valko	Vol #:	59

C 2826	P. Lawrence	Vol #:	59

C 2827	N. Ashburn	Vol #:	59

C 2828	M. Matthews	Vol #:	59

C 2829	D. Waddell	Vol #:	59

C 2830	M. Markwell	Vol #:	59

C 2831	N. Manus	Vol #:	59

C 2832	A. Brittingham	Vol #:	59

C 2833	S. Connell	Vol #:	59

C 2834	J. Harmer	Vol #:	59

C 2835	H. Puterbaugh	Vol #:	59

C 2836	C. Reynolds	Vol #:	59

C 2837	M. Fast	Vol #:	59

C 2838	F. Ramirez	Vol #:	59

C 2839	K. Turner	Vol #:	59

C 2840	G. Maltinski	Vol #:	59

C 2841	G. Nelson	Vol #:	59

C 2842	E. HAwthorne	Vol #:	59

C 2843	Dr. M. Robinson, DVM	Vol #:	59

C 2844	M. Dixon	Vol #:	59

C 2845	S. Wilbur	Vol #:	59

C 2846	S. Ayoub	Vol #:	59

C 2847	Dr. Burgess	Vol #:	59



C 2848	D. Burgess	Vol #:	59

C 2849	R. Chaikin	Vol #:	59

C 2850	K. Dundon	Vol #:	59

C 2851	C. Roseh	Vol #:	59

C 2852	B. Covyeau	Vol #:	59

C 2853	D. Langer	Vol #:	59

C 2854	M. Stevens	Vol #:	59

C 2855	S. Majchrzall	Vol #:	59

C 2856	D. Koory	Vol #:	59

C 2857	L. Samuel	Vol #:	59

C 2858	H. Miles	Vol #:	59

C 2859	A. Miles	Vol #:	59

C 2860	L. Drake	Vol #:	59

C 2861	B. Scott	Vol #:	59

C 2862	V. Walton	Vol #:	59

C 2863	M. Wheeler	Vol #:	59

C 2864	G. Green	Vol #:	59

C 2865	J. Butterfield	Vol #:	59

C 2866	J. Smith	Vol #:	59

C 2867	M. King	Vol #:	59

C 2868	M. Molinari	Vol #:	59

C 2869	S. Zakroff	Vol #:	59

C 2870	B. Covyeau	Vol #:	59

C 2871	C. Bowes	Vol #:	59

C 2872	C. Bell	Vol #:	59

C 2873	W. Hauser	Vol #:	59

C 2874	P. Butterfield	Vol #:	59

C 2875	C. Condon	Vol #:	59

C 2876	P. Butterfield	Vol #:	59

C 2877	A. Mitchell	Vol #:	59

C 2878	J. Elliott	Vol #:	59

C 2879	J. Holub	Vol #:	59

C 2880	J. Elliott	Vol #:	59

C 2881	T. Mestemacher	Vol #:	59

C 2882	E. Jarvis	Vol #:	59

C 2883	D. Mathies	Vol #:	59

C 2884	S. Marlowe	Vol #:	59



C 2885	L. Alvarez	Vol #:	59

C 2886	J. Abdai	Vol #:	59

C 2887	J. Gehrisch	Vol #:	59

C 2888	R. Mehnik	Vol #:	59

C 2889	S. Clair	Vol #:	59

C 2890	R. Enticknop	Vol #:	59

C 2891	F. Oliva	Vol #:	59

C 2892	E. Birnbaum	Vol #:	59

C 2893	M. Bowers	Vol #:	59

C 2894	S. Oster	Vol #:	59

C 2895	A. Klepfer	Vol #:	59

C 2896	J. Myers	Vol #:	59

C 2897	V. Falero	Vol #:	59

C 2898	S. Reiter	Vol #:	59

C 2899	M. Ankeney	Vol #:	59

C 2900	K. Shore	Vol #:	59

C 2901	G. Zaromba	Vol #:	59

C 2902	C. Spiess	Vol #:	59

C 2903	C. Griswold	Vol #:	59

C 2904	B. Pierson	Vol #:	59

C 2905	S. Strand	Vol #:	59

C 2906	J. Rose	Vol #:	59

C 2907	E. Lindsey	Vol #:	59

C 2908	P. Attardo	Vol #:	59

C 2909	J. Oberg	Vol #:	59

C 2910	B. Tegeler	Vol #:	59

C 2911	M. Tegeler	Vol #:	59

C 2912	L. Brown	Vol #:	59

C 2913	S. Schweiss	Vol #:	59

C 2914	B. Burkholder	Vol #:	59

C 2915	J. Otril	Vol #:	59

C 2916	J. Baldwin	Vol #:	59

C 2917	S. Farrar	Vol #:	59

C 2918	J. Hammond	Vol #:	59

C 2919	K. Iwanyshyn	Vol #:	59

C 2920	J. Mellor	Vol #:	59

C 2921	A. Wyant, MD	Vol #:	59



C 2922	P. Nelson	Vol #:	59

C 2923	R. Armour	Vol #:	59

C 2924	K. Carter	Vol #:	59

C 2925	S. Farrar	Vol #:	59

C 2926	H. Barker	Vol #:	59

C 2927	K. Carter	Vol #:	59

C 2928	K. Markel	Vol #:	59

C 2929	R. Rich	Vol #:	59

C 2930	M. Stephens	Vol #:	59

C 2931	A. Zeid, MD	Vol #:	60

C 2932	D. Zehren	Vol #:	60

C 2933	V. Draskonich	Vol #:	60

C 2934	M. Lance	Vol #:	59

C 2935	J. Trenary	Vol #:	59

C 2936	Z. Sallam	Vol #:	59

C 2937	E. Kelly	Vol #:	60

C 2938	B. Martinsons	Vol #:	60

C 2939	C. Pippis	Vol #:	60

C 2940	S. Lorraine	Vol #:	60

C 2941	Eligible	Vol #:	60

C 2942	J. Kramor	Vol #:	60

C 2943	V. Kurz	Vol #:	60

C 2944	P. Levinson	Vol #:	60

C 2945	A. Kupecz	Vol #:	60

C 2946	M. Sketchley	Vol #:	60

C 2947	S. Nelson	Vol #:	60

C 2948	D. Hansen	Vol #:	60

C 2949	J. Edmonds	Vol #:	60

C 2950	B. Henry	Vol #:	60

C 2951	A. Grinberg	Vol #:	60

C 2952	G. Elbogen	Vol #:	60

C 2953	P. Zinck	Vol #:	60

C 2954	D. Ripose	Vol #:	60

C 2955	B. Magarilli	Vol #:	60

C 2956	W. Blondin	Vol #:	60

C 2957	L. Severson	Vol #:	60

C 2958	B. Early	Vol #:	60



C 2959	H. Walbert	Vol #:	60

C 2960	P. Johnson	Vol #:	60

C 2961	M. Scheffert	Vol #:	60

C 2962	A. Barros	Vol #:	60

C 2963	V. Hofacher	Vol #:	60

C 2964	B. Reynolds	Vol #:	60

C 2965	M. Humphrey	Vol #:	60

C 2966	M. Simon	Vol #:	60

C 2967	D. VanHaaften	Vol #:	60

C 2968	H. Tomlinson	Vol #:	60

C 2969	N. Haxaire	Vol #:	60

C 2970	M. Edwardo	Vol #:	60

C 2971	F. Hynds	Vol #:	60

C 2972	C. Callen	Vol #:	60

C 2973	V. Dasilva	Vol #:	60

C 2974	M. Grimsley	Vol #:	60

C 2975	S. Fetherston	Vol #:	60

C 2976	J. Zehoruski	Vol #:	60

C 2977	J. Hunter	Vol #:	60

C 2978	P. Dismore	Vol #:	60

C 2979	W. Key	Vol #:	60

C 2980	R. Fullerton	Vol #:	60

C 2981	P. Kennedy	Vol #:	60

C 2982	P. Berry	Vol #:	60

C 2983	P. Bannon	Vol #:	60

C 2984	M. Ehee	Vol #:	60

C 2985	J. Lind	Vol #:	60

C 2986	D. Effertz	Vol #:	60

C 2987	H. Trudeau	Vol #:	60

C 2988	C. Burton	Vol #:	60

C 2989	P. Sielaff	Vol #:	60

C 2990	V. Chambers	Vol #:	60

C 2991	J. McKay	Vol #:	60

C 2992	J. Putnam	Vol #:	60

C 2993	J. Bienkowski	Vol #:	60

C 2994	G. Botti	Vol #:	60

C 2995	M. Fay	Vol #:	60



C 2996	M. Gilmartin	Vol #:	60

C 2997	J. Long	Vol #:	60

C 2998	L. Ojeda, PhD	Vol #:	60

C 2999	J. Fincher	Vol #:	60

C 3000	J. Buller	Vol #:	60

C 3001	R. Pearson	Vol #:	60

C 3002	H. Chase	Vol #:	60

C 3003	C. Snika	Vol #:	60

C 3004	P. Pearce	Vol #:	60

C 3005	J. Glissmeyer	Vol #:	60

C 3006	J. McElroy	Vol #:	60

C 3007	S. Qualls	Vol #:	60

C 3008	A. Schreder	Vol #:	60

C 3009	M. Jackson	Vol #:	60

C 3010	M. Mohler	Vol #:	60

C 3011	B. Anderson	Vol #:	60

C 3012	W. Andrus, M.D.	Vol #:	60

C 3013	J. Abdouch	Vol #:	60

C 3014	K. Haber	Vol #:	60

C 3015	J. Brooker	Vol #:	60

C 3016	C. Habets	Vol #:	60

C 3017	R. McGill	Vol #:	60

C 3018	V. Speck	Vol #:	60

C 3019	B. Cohen	Vol #:	60

C 3020	A. Markley	Vol #:	60

C 3021	J. Thomas	Vol #:	60

C 3022	D. Cooper	Vol #:	60

C 3023	J. Brown	Vol #:	60

C 3024	M. Brown	Vol #:	60

C 3025	S. Ruzgerian	Vol #:	60

C 3026	L. Krafsur	Vol #:	60

C 3027	L. Bare	Vol #:	60

C 3028	J. Lynn	Vol #:	60

C 3029	A. Berry	Vol #:	60

C 3030	C. Gura	Vol #:	60

C 3031	V. Cowan	Vol #:	60

C 3032	Jan H.	Vol #:	60



C 3033	C. Conde	Vol #:	60

C 3034	R. Stuart	Vol #:	60

C 3035	F. Schnipper	Vol #:	60

C 3036	K. Sobczak	Vol #:	60

C 3037	S. Ockerlander	Vol #:	60

C 3038	K. Marott	Vol #:	60

C 3039	V. Smith	Vol #:	60

C 3040	S. Simpson	Vol #:	60

C 3041	F. Otto	Vol #:	60

C 3042	L. England	Vol #:	60

C 3043	A. Fredrick	Vol #:	60

C 3044	D. Smith	Vol #:	60

C 3045	B. Clauss	Vol #:	60

C 3046	B. Clauss	Vol #:	60

C 3047	A. Vining	Vol #:	60

C 3048	M. McCart, PhD	Vol #:	60

C 3049	C. DeLucca	Vol #:	60

C 3050	J. Prescott	Vol #:	60

C 3051	M. Cantieri, DO	Vol #:	60

C 3052	J. Jackson	Vol #:	60

C 3053	K. Parker	Vol #:	60

C 3054	T. Tyson	Vol #:	60

C 3055	E. Ringle	Vol #:	60

C 3056	S. Gettlman	Vol #:	60

C 3057	J. Anderson	Vol #:	60

C 3058	L. Hodges	Vol #:	60

C 3059	M. Sly	Vol #:	60

C 3060	Dr. J. Cook	Vol #:	60

C 3061	S. Boege	Vol #:	61

C 3062	P. Arnone	Vol #:	60

C 3063	D. Horn	Vol #:	60

C 3064	J. Solda	Vol #:	61

C 3065	G. Tegl	Vol #:	61

C 3066	R. Mashler	Vol #:	60

2006FL-0120	Food Allergency Labeling Notification (FALN): Anyhydrous Lactitol and Lactitol Monohydrate

FLN 1	Danisco USA Inc	Vol #:	1



2006P-0114	Refrain from taking administrative action regarding approval and/or effective date of final approval of any and all ANDAs for a generic version of Metrogel-Vaginal 0.75%

ACK 1	HFA-305 to Foley & Lardner LLP	Vol #:	1

2006P-0117	Declare that Omeprazole Tablets, 20 mg (proposed formulation), is suitable for submission aas an ANDA

ACK 1	HFA-305 to QPharma, LLC	Vol #:	1

CP 1	QPharma, LLC	Vol #:	1

2006P-0120	Enforce ban on carbon monoxide in the packaging of fresh tuna and fresh tuna that is subsequently frozen

ACK 1	HFA-305 to EnviroWatch, Inc.	Vol #:	1

CP 1	EnviroWatch, Inc.	Vol #:	1

2006V-0119	Laser Light Show

ACK 1	HFA-305 to Mero Productions	Vol #:	1

VAR 1	Mero Productions	Vol #:	1

Page created on May 15, 2006 RSC

FDA/Dockets Management