Dockets Entered on July 13, 2006


Dockets Management
	Dockets Entered On July 13, 2006 Table of Contents



	Docket #	Title

	1998D-0315	Instructions for Submitting Electronic Lot Release Protocols

	2003D-0478	Guidance on Marketed Unapproved Drugs Compliance Policy Guide

	2004P-0339	Refuse to file an ANDA for the combination drug amlodipine besylate-benazepril hydrochloride (amlodipine-benazepril)

	2005H-0271	Civil Money Penalty: TMJ Implants, Inc.

	2005N-0437	Medical Gas Containers and Closures; Current Good Manufacturing

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

	2006D-0226	Prescription Drug Marketing Act Pedigree Requirements under 21 CFR Part 203; Effective Date and Compliance Policy GuideProgram, Draft Guidance; Availability

	2006N-0181	Product Stability Data: Notice of Pilot Project

	2006P-0151	Stay the current approvable letter with conditions of any and all Premarket Applications for silicone gel-filled breast implants

	2006P-0177	ANDA Suitability for Methotrexate

	1998D-0315	Instructions for Submitting Electronic Lot Release Protocols

	GDL 2	Guideline	Vol #:	1

	NAD 2	FDA	Vol #:	1

	2003D-0478	Guidance on Marketed Unapproved Drugs Compliance Policy Guide

	EC 27	Ms. Jennifer MacSwain	Vol #:	5

	2004P-0339	Refuse to file an ANDA for the combination drug amlodipine besylate-benazepril hydrochloride (amlodipine-benazepril)

	PAV 1	FDA/CDER to Fommer Lawrence & Haug LLP	Vol #:	1

	2005H-0271	Civil Money Penalty: TMJ Implants, Inc.

	MO 14	FDA/CDDDRH/OGC	Vol #:	6

	2005N-0437	Medical Gas Containers and Closures; Current Good Manufacturing

	C 37	Cryogenic Vessel Alternatives	Vol #:	3

	C 38	Tech Air of Connecticut, Inc.	Vol #:	3

	C 39	Corp Brother, Inc.	Vol #:	3

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

	C 15491	S. Carden	Vol #:	172

	C 15492	J. Baran	Vol #:	172

	C 15493	G. Weitzel	Vol #:	172

	C 15494	J. Montgomery	Vol #:	172

	C 15495	D. Hudrich	Vol #:	172

	C 15496	J. Sargent	Vol #:	172

	C 15497	J. Malkin	Vol #:	172

	C 15498	M. Caldwell	Vol #:	172



C 15499	K. Gohnert	Vol #:	172

C 15500	D. Gilcrist	Vol #:	172

C 15501	P. Vymazal	Vol #:	172

C 15502	L. Purvines	Vol #:	172

C 15503	P. Hansen	Vol #:	172

C 15504	A. Morris	Vol #:	172

C 15505	C. Jabbon	Vol #:	172

C 15506	F. Free	Vol #:	172

C 15507	S. Hansen	Vol #:	172

C 15508	J. Minnis	Vol #:	172

C 15509	M. Taylor	Vol #:	172

C 15510	C. McGhee	Vol #:	172

C 15511	C. Haning	Vol #:	172

C 15512	G. Lentz	Vol #:	172

C 15513	S. Lentz	Vol #:	172

C 15514	D. Walker	Vol #:	172

C 15515	E. Schickling	Vol #:	172

C 15516	T. Boteler	Vol #:	172

C 15517	P. Renander	Vol #:	172

C 15518	G. Schilling	Vol #:	172

C 15519	L. Bell	Vol #:	172

C 15520	S. Perretano	Vol #:	172

C 15521	J. Law	Vol #:	172

C 15522	L. Merleau	Vol #:	172

C 15523	L. House	Vol #:	172

C 15524	S. Ortolano	Vol #:	172

C 15525	A. Wilson	Vol #:	172

C 15526	C. Keany	Vol #:	172

C 15527	K. Mys	Vol #:	172

C 15528	W. Kali	Vol #:	172

C 15529	C. Farmer	Vol #:	172

C 15530	T. Maxwell	Vol #:	172

C 15531	D. Briggs	Vol #:	172

C 15532	S. Wilcox	Vol #:	172

C 15533	R. Brown	Vol #:	172

C 15534	J. Gaddes	Vol #:	172

C 15535	K. Rotramel	Vol #:	172



C 15536	J. Colombo	Vol #:	173

C 15537	L. Orischak	Vol #:	173

C 15538	D. Gillaspie	Vol #:	173

C 15539	C. Land	Vol #:	173

C 15540	E. Watson	Vol #:	173

C 15541	G. Mayes	Vol #:	173

C 15542	M. Littlejohn	Vol #:	173

C 15543	L. Loveless	Vol #:	173

C 15544	S. Maxey	Vol #:	173

C 15545	D. Johansen	Vol #:	173

C 15546	C. Allen	Vol #:	173

C 15547	C. Hayfield	Vol #:	173

C 15548	L. Little	Vol #:	173

C 15549	K. Lewis	Vol #:	173

C 15550	C. Slade	Vol #:	173

C 15551	K. Haynie	Vol #:	173

C 15552	B. Short	Vol #:	173

C 15553	D. Molnar	Vol #:	173

C 15554	S. Houghton	Vol #:	173

C 15555	L. Tolerce	Vol #:	173

C 15556	C. Grassi	Vol #:	173

C 15557	N. Cullen	Vol #:	173

C 15558	P. Livingston	Vol #:	173

C 15559	A. Mitchell	Vol #:	173

C 15560	R. Andian	Vol #:	173

C 15561	M. Howe	Vol #:	173

C 15562	C. Hossein	Vol #:	173

C 15563	W. Cyr	Vol #:	173

C 15564	T. Brown	Vol #:	173

C 15565	M. O'Connor	Vol #:	173

C 15566	J. Smith	Vol #:	173

C 15567	S. Stevens	Vol #:	173

C 15568	D. Covington	Vol #:	173

C 15569	I. Rameau	Vol #:	173

C 15570	A. Barrio	Vol #:	173

C 15571	L. Ramsey	Vol #:	173

C 15572	D. Gilbert	Vol #:	173



C 15573	P. Young	Vol #:	173

C 15574	M. McKelvy	Vol #:	173

C 15575	A. Fritzges	Vol #:	173

C 15576	R. Collins	Vol #:	173

C 15577	F. Postma	Vol #:	173

C 15578	F. Hirsch	Vol #:	173

C 15579	B. Krepps	Vol #:	173

C 15580	N. Becker	Vol #:	173

C 15581	M. Schaeffer	Vol #:	173

C 15582	C. Patzau	Vol #:	173

C 15583	M. Walker	Vol #:	173

C 15584	J. Brockett	Vol #:	173

C 15585	A. Blant	Vol #:	173

C 15586	G. Herman	Vol #:	173

C 15587	H. Sheikholeslami	Vol #:	173

C 15588	J. Summers	Vol #:	173

C 15589	P. Lynch	Vol #:	173

C 15590	D. Norton	Vol #:	173

C 15591	N. Tatum	Vol #:	173

C 15592	B. Briggs	Vol #:	173

C 15593	Texas Pharmacy Association	Vol #:	173

C 15594	H. Klimmem	Vol #:	173

C 15595	V. Smith	Vol #:	173

C 15596	A. Tottossy	Vol #:	173

C 15597	I. Anderson	Vol #:	173

C 15598	J. Floch	Vol #:	173

C 15599	J. Hanson	Vol #:	173

C 15600	C. Cook	Vol #:	173

C 15601	J. Chepe	Vol #:	173

C 15602	A. Samaid	Vol #:	173

C 15603	B. Quinlan	Vol #:	173

C 15604	M. Marks	Vol #:	173

C 15605	N. Maddox	Vol #:	173

C 15606	R. McClain	Vol #:	173

C 15607	J. Grke	Vol #:	173

C 15608	P. Perino	Vol #:	173

C 15609	J. Perino	Vol #:	173



C 15610	C. Bakbieri	Vol #:	173

C 15611	L. Giampa	Vol #:	173

C 15612	C. Calo	Vol #:	173

C 15613	J. Redmond	Vol #:	173

C 15614	L. Crowley	Vol #:	173

C 15615	D. Schneider	Vol #:	173

C 15616	R. Ballengar	Vol #:	173

C 15617	M. Young	Vol #:	173

C 15618	V. Barzelaito	Vol #:	173

C 15619	V. Anderson	Vol #:	173

C 15620	J. Randolph	Vol #:	173

C 15621	D. Dedman	Vol #:	173

C 15622	S. Cookman	Vol #:	173

C 15623	A. Esparza	Vol #:	173

C 15624	L. Egg	Vol #:	173

C 15625	S. Mullins	Vol #:	173

C 15626	M. Daugul	Vol #:	173

C 15627	R. Lies	Vol #:	173

C 15628	J. Goldston	Vol #:	173

C 15629	P. Oakes	Vol #:	173

C 15630	C. Sorling	Vol #:	173

C 15631	J. Munyer	Vol #:	173

C 15632	J. Fishler	Vol #:	173

C 15633	E. McCracken	Vol #:	173

C 15634	S. Watson	Vol #:	173

C 15635	The Victory Studios	Vol #:	173

C 15636	C. Stephens	Vol #:	173

C 15637	E. Lenz	Vol #:	173

C 15638	M. Rodger	Vol #:	173

C 15639	G. St. John	Vol #:	173

C 15640	E. Luger	Vol #:	173

C 15641	L. Peralta	Vol #:	173

C 15642	D. Vega	Vol #:	173

C 15643	T. Southard	Vol #:	173

C 15644	P. Wilson	Vol #:	173

C 15645	E. Stucky	Vol #:	173

C 15646	D. Strathdee	Vol #:	173



C 15647	T. Fowler	Vol #:	173

C 15648	P. Whitehead	Vol #:	173

C 15649	A. Smith	Vol #:	173

C 15650	J. Hildabrand	Vol #:	173

C 15651	L. VanSteenuyk	Vol #:	173

C 15652	C. Willis	Vol #:	173

C 15653	I. Seidel	Vol #:	173

C 15654	D. Everts	Vol #:	173

C 15655	J. Scantland	Vol #:	173

C 15656	C. Salon	Vol #:	173

C 15657	A. Schlichte	Vol #:	173

C 15658	T. Broutler	Vol #:	173

C 15659	K. Grose	Vol #:	173

C 15660	B. Pouile	Vol #:	173

C 15661	K. Boettcher	Vol #:	173

C 15662	D. Hemphill	Vol #:	173

C 15663	S. Williams	Vol #:	173

C 15664	F. Gardis	Vol #:	173

C 15665	M. Neary	Vol #:	173

C 15666	W. Hu	Vol #:	173

C 15667	N. Sekowski	Vol #:	173

C 15668	P. Benton	Vol #:	173

C 15669	B. Prince	Vol #:	173

C 15670	J. McVean	Vol #:	173

C 15671	L. Diggs	Vol #:	173

C 15672	B. Ernst	Vol #:	173

C 15673	E. Johnson	Vol #:	173

C 15674	K. Ahrend	Vol #:	173

C 15675	K. Coffey	Vol #:	173

C 15676	S. Khanna	Vol #:	173

C 15677	C. Keefer	Vol #:	173

C 15678	V. Estronic	Vol #:	173

C 15679	S. Sulanson	Vol #:	173

C 15680	K. Peterson	Vol #:	173

C 15681	J. Hanley	Vol #:	173

C 15682	R. Wheeler	Vol #:	173

C 15683	P. Burbey	Vol #:	173



C 15684	G. Neff	Vol #:	173

C 15685	C. Frysinger	Vol #:	173

C 15686	C. Mills	Vol #:	173

C 15687	J. Bean	Vol #:	173

C 15688	N. Derda	Vol #:	173

C 15689	G. Ludwick	Vol #:	173

C 15690	G. Ludwick	Vol #:	173

C 15691	J. Staser	Vol #:	173

C 15692	P. Diamond	Vol #:	173

C 15693	M. Selzer	Vol #:	173

C 15694	C. Yoder	Vol #:	173

C 15695	M. Hebert	Vol #:	173

C 15696	Z. Johnson	Vol #:	173

C 15697	B. Collector	Vol #:	173

C 15698	J. Feucht	Vol #:	173

C 15699	P. Avery	Vol #:	173

C 15700	Illegible	Vol #:	174

C 15701	B. Claxton	Vol #:	174

C 15702	P. Williams	Vol #:	174

C 15703	E. Pionessa	Vol #:	174

C 15704	M. Husnick	Vol #:	174

C 15705	L. Kennedy-Piccian	Vol #:	174

C 15706	S. Dale	Vol #:	174

C 15707	T. Rothrock	Vol #:	174

C 15708	A. Adams	Vol #:	174

C 15709	J. Lee	Vol #:	174

C 15710	C. Myers	Vol #:	174

C 15711	Northampton Wellness Associates, L. L. C.	Vol #:	174

C 15712	D. Russell	Vol #:	174

C 15713	J. Neumeier	Vol #:	174

C 15714	P. Gamache	Vol #:	174

C 15715	K. Doyle	Vol #:	174

C 15716	K. Chung	Vol #:	174

C 15717	M. Aspland	Vol #:	174

C 15718	Z. Soroudi	Vol #:	174

C 15719	I. Rameau	Vol #:	174

C 15720	M. Estes	Vol #:	174



C 15721	N. Harkins	Vol #:	174

C 15722	K. Elflein	Vol #:	174

C 15723	C. Sewell	Vol #:	174

C 15724	W. Ostlund	Vol #:	174

C 15725	L. Wilcox	Vol #:	174

C 15726	B. De Haven	Vol #:	174

C 15727	R. Steffen	Vol #:	174

C 15728	W. Christianson	Vol #:	174

C 15729	G. Lehman	Vol #:	174

C 15730	M. Garner	Vol #:	174

C 15731	C. Mullins	Vol #:	174

C 15732	M. Andreas	Vol #:	174

C 15733	M. Holt	Vol #:	174

C 15734	G. Lehman	Vol #:	174

C 15735	R. Morgante	Vol #:	174

C 15736	M. Holt	Vol #:	174

C 15737	M. Andreas	Vol #:	174

C 15738	C. Mullins	Vol #:	174

C 15739	T. Fowler	Vol #:	174

C 15740	P. Whitehead	Vol #:	174

C 15741	A. Smith	Vol #:	174

C 15742	R. Blake	Vol #:	174

C 15743	J. Meyer	Vol #:	174

C 15744	T. Adelhardt	Vol #:	174

C 15745	L. Dalton	Vol #:	174

C 15746	J. Barrio	Vol #:	174

C 15747	C. Atchley	Vol #:	174

C 15748	L. Campbell	Vol #:	174

C 15749	L. Smith	Vol #:	174

C 15750	FDA/DDM to Patricia Weiss	Vol #:	174

C 15751	T. Barnes	Vol #:	174

C 15752	R. Blair	Vol #:	174

C 15753	R. Hazen	Vol #:	174

C 15754	D. Hicks	Vol #:	174

C 15755	C. Hicks	Vol #:	174

C 15756	C. Stansberg	Vol #:	174

C 15757	J. Ramsey	Vol #:	174



C 15758	J. Jackson	Vol #:	174

C 15759	V. Jackson	Vol #:	174

C 15760	E. Assouline	Vol #:	174

C 15761	C. Weissert	Vol #:	174

C 15762	S. Campbell	Vol #:	174

C 15763	N. Wall	Vol #:	174

C 15764	M. McCoy	Vol #:	174

C 15765	C. Garrett	Vol #:	174

C 15766	K. Palmer	Vol #:	174

C 15767	J. Deats	Vol #:	174

C 15768	J. Loyd	Vol #:	174

C 15769	P. Erickson	Vol #:	174

C 15770	T. Alltop	Vol #:	174

C 15771	V. Sorensen	Vol #:	174

C 15772	C. DeLauter	Vol #:	174

C 15773	J. Furey	Vol #:	174

C 15774	J. Beltran	Vol #:	174

C 15775	J. Oates	Vol #:	174

C 15776	C. Mathieu	Vol #:	174

C 15777	S. Welch	Vol #:	174

C 15778	O. McNab	Vol #:	174

C 15779	N. Pullins	Vol #:	174

C 15780	C. Atwood	Vol #:	174

C 15781	B. Johnson	Vol #:	174

C 15782	L. Wilkins	Vol #:	174

C 15783	M. Isaffels	Vol #:	174

C 15784	D. Matthews	Vol #:	174

C 15785	J. Bloomfield	Vol #:	174

C 15786	K. Frantum	Vol #:	174

C 15787	A. Sanders	Vol #:	174

C 15788	B. Albus	Vol #:	174

C 15789	D. Brennan	Vol #:	174

C 15790	J. Munyer	Vol #:	174

C 15791	A. Long	Vol #:	174

C 15792	D. Lendon	Vol #:	174

C 15793	M. Small	Vol #:	174

C 15794	C. Kiedaiscet	Vol #:	174



C 15795	B. Burke	Vol #:	174

C 15796	J. Mullen	Vol #:	174

C 15797	J. Farnol	Vol #:	174

C 15798	K. Higgins	Vol #:	175

C 15799	M. Garner	Vol #:	175

C 15800	A. Davis	Vol #:	175

C 15801	P. Mills	Vol #:	175

C 15802	M. Gilbert	Vol #:	175

C 15803	L. Davis	Vol #:	175

C 15804	D. Parrish	Vol #:	175

C 15805	L. Johnson	Vol #:	175

C 15806	S.	Vol #:	175

C 15807	E. Teasley	Vol #:	175

C 15808	S. Phillips	Vol #:	175

C 15809	S. Tinsley	Vol #:	175

C 15810	C. Nichols	Vol #:	175

C 15811	R. Wilson	Vol #:	175

C 15812	D. Carter	Vol #:	175

C 15813	J. Lemon	Vol #:	175

C 15814	B. Taylor	Vol #:	175

C 15815	D. Galloway	Vol #:	175

C 15816	J. Prescott	Vol #:	175

C 15817	R. Blum	Vol #:	175

C 15818	J. Teutsch	Vol #:	175

C 15819	C. Hahn	Vol #:	175

C 15820	L. Urban	Vol #:	175

C 15821	N. Seitz	Vol #:	175

C 15822	S. Mills	Vol #:	175

C 15823	S. Tropfenbaum	Vol #:	175

C 15824	D. Crawford	Vol #:	175

C 15825	S. Reams	Vol #:	175

C 15826	D. Rowe	Vol #:	175

C 15827	A. Forsythe	Vol #:	175

C 15828	C. Davis	Vol #:	175

C 15829	S. Breck	Vol #:	175

C 15830	M. Smutnak	Vol #:	175

C 15831	D. Hudson	Vol #:	175



C 15832	K. Twolan	Vol #:	175

C 15833	K. Nordstrom	Vol #:	175

C 15834	C. Teten	Vol #:	175

C 15835	R. Reischneider	Vol #:	175

C 15836	L. Oissar	Vol #:	175

C 15837	C. Reitheford	Vol #:	175

C 15838	M. Kloche	Vol #:	175

C 15839	M. Johnston	Vol #:	175

C 15840	S. White	Vol #:	175

C 15841	K. Tonning	Vol #:	175

C 15842	K. Tonning	Vol #:	175

C 15843	T. LaVance	Vol #:	175

C 15844	C. Huson	Vol #:	175

C 15845	E. Hobbs	Vol #:	175

C 15846	K. Moore	Vol #:	175

C 15847	M. Cassata	Vol #:	175

C 15848	R. Hobbs	Vol #:	175

C 15849	T. Longosarb	Vol #:	175

C 15850	R. Baker	Vol #:	175

C 15851	P. Franzone	Vol #:	175

C 15852	M. Carlson	Vol #:	175

C 15853	D. Fitzsimmons	Vol #:	175

C 15854	P. Mulch	Vol #:	175

C 15855	R. Mintern	Vol #:	175

C 15856	R. Mintern	Vol #:	175

C 15857	S. Smith	Vol #:	175

C 15858	H. Kummem	Vol #:	175

EC 33249	Mrs. Rene Kuttenkuler	Vol #:	142

EMC 3036	C. Larson	Vol #:	157

EMC 3037	L. Ruyter	Vol #:	157

EMC 3038	L. Carbin	Vol #:	157

EMC 3039	Dr. R. Esrig	Vol #:	157

EMC 3040	K. Martz	Vol #:	157

EMC 3041	Dr. K. Fox	Vol #:	157

EMC 3042	C. Nicolaus, RPh	Vol #:	157

EMC 3043	J. Johnson	Vol #:	157

EMC 3044	M. Oberacker	Vol #:	157



EMC 3045	M. Oberacker	Vol #:	157

EMC 3046	M. Wickenhauser	Vol #:	157

EMC 3047	B. Phillips	Vol #:	157

EMC 3048	J. Marin	Vol #:	157

EMC 3049	C. Schicker	Vol #:	157

EMC 3050	K. Rice	Vol #:	157

EMC 3051	S. Scheliga	Vol #:	157

EMC 3052	D. Wiedinmyer	Vol #:	157

EMC 3053	R. Wooley	Vol #:	157

EMC 3054	S. Winters	Vol #:	157

EMC 3055	D. Bungert	Vol #:	157

EMC 3056	L. Brown	Vol #:	157

EMC 3057	S. Phillips	Vol #:	157

EMC 3058	C. Funk	Vol #:	157

EMC 3059	C. Funk	Vol #:	157

EMC 3060	S. Moldenhauer	Vol #:	157

EMC 3061	C. Bowyer	Vol #:	157

EMC 3062	G. Lozano	Vol #:	157

EMC 3063	C. Thomas	Vol #:	157

EMC 3064	N. Andresen	Vol #:	157

EMC 3065	L. Morse	Vol #:	157

EMC 3066	G. Hepner	Vol #:	157

EMC 3067	F. Longmire	Vol #:	157

EMC 3068	F. Coorpender	Vol #:	157

EMC 3069	Dr. D. Ingle	Vol #:	157

EMC 3070	J. Duca	Vol #:	157

EMC 3071	R. Saylor	Vol #:	157

EMC 3072	B. Donnelly	Vol #:	157

EMC 3073	Dr. A. Swan	Vol #:	157

EMC 3074	D. Caless	Vol #:	157

EMC 3075	F. Niedz	Vol #:	157

EMC 3076	M. Brown	Vol #:	157

EMC 3077	N. Halberstadt	Vol #:	157

EMC 3078	H. Dallas	Vol #:	157

EMC 3079	C. Pacocha	Vol #:	157

EMC 3080	H. Dallas	Vol #:	157

EMC 3081	H. Dallas	Vol #:	157



EMC 3082	H. Dallas	Vol #:	157

EMC 3083	S. Hill, PhD	Vol #:	157

EMC 3084	C. Arians	Vol #:	157

EMC 3085	M. Marksmeier	Vol #:	157

EMC 3086	P. Taylor	Vol #:	157

EMC 3087	C. Hodge	Vol #:	157

EMC 3088	L. Schorr	Vol #:	157

EMC 3089	C. Czarny	Vol #:	157

EMC 3090	S. Batchelar	Vol #:	157

EMC 3091	J. Khoury	Vol #:	157

EMC 3092	M. Grabe	Vol #:	157

EMC 3093	C. Bowyer	Vol #:	157

EMC 3094	D. Sullivan	Vol #:	157

EMC 3095	S. Neubauer	Vol #:	157

EMC 3096	E. Buonpane	Vol #:	157

EMC 3097	N. Tashjian	Vol #:	157

EMC 3098	N. Tashjian	Vol #:	157

EMC 3099	V. Dueppe	Vol #:	157

EMC 3100	L. Henry	Vol #:	157

EMC 3101	A. Balmer	Vol #:	157

EMC 3102	R. McDonald	Vol #:	157

EMC 3103	G. Higaki	Vol #:	157

EMC 3104	B. Bichlmeir	Vol #:	157

EMC 3105	C. Mikish	Vol #:	157

EMC 3106	L. TOrres	Vol #:	157

EMC 3107	M. Fullmer	Vol #:	157

EMC 3108	C> LArson	Vol #:	157

EMC 3109	K. Parker	Vol #:	157

EMC 3110	D. Loughry	Vol #:	157

EMC 3111	D. Loughry	Vol #:	157

EMC 3112	J. Adams	Vol #:	157

EMC 3113	D. Vincent	Vol #:	157

EMC 3114	D. Caruthers	Vol #:	157

EMC 3115	D. Caruthers	Vol #:	157

EMC 3116	H. Carter	Vol #:	157

EMC 3117	S. Ferraresi	Vol #:	157

EMC 3118	D. Bruschi	Vol #:	157



EMC 3119	M. Francis	Vol #:	157

EMC 3120	M. Francis	Vol #:	157

EMC 3121	L. Macias	Vol #:	157

EMC 3122	P. Hughes	Vol #:	157

EMC 3123	R. Ferris	Vol #:	157

EMC 3124	P. Hughes	Vol #:	157

EMC 3125	L. Emmerich	Vol #:	157

EMC 3126	L. Emmerich	Vol #:	157

EMC 3127	D. PAngborn	Vol #:	157

EMC 3128	J. Smith	Vol #:	157

EMC 3129	L. Gouveia	Vol #:	157

EMC 3130	M. D'Angona	Vol #:	157

EMC 3131	J. BArrilleaux	Vol #:	157

EMC 3132	J. BArrilleaux	Vol #:	157

EMC 3133	C. Condon	Vol #:	157

EMC 3134	E. Stisher	Vol #:	157

EMC 3135	R. Feil	Vol #:	157

2006D-0226	Prescription Drug Marketing Act Pedigree Requirements under 21 CFR Part 203; Effective Date and Compliance Policy GuideProgram, Draft Guidance; Availability

EC 1	Pfizer Inc.	Vol #:	1

2006N-0181	Product Stability Data: Notice of Pilot Project

EC 6	Sepracor Inc.	Vol #:	1

2006P-0151	Stay the current approvable letter with conditions of any and all Premarket Applications for silicone gel-filled breast implants

EC 620	Miss. kelly thompon	Vol #:	3

EC 621	Mrs. maryann salamon	Vol #:	3

EC 622	Ms. Heidi Siegfried	Vol #:	3

2006P-0177	ANDA Suitability for Methotrexate

C 1	D. Lowe	Vol #:	1

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