Dockets Entered on June 12, 2006

Dockets Management



Dockets Entered On June 12, 2006



Docket #	Title

1988N-0242	Hydrocortisone Acetate/Pramoxine HCL/Opportunity/Hearing

1997S-0162	30-Day Structure Function Claim Notification Letters Dietary

1998P-0151	Introduction Of Downed Cattle Into The Food Supply

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

2005P-0493	Establish criteria, analogous to the criteria for marketing Category I drug products under OTC Drug Review regarding the substitutability of prescription hyoscyamine drug products

2005P-0498	Criteria of generic version of Wellbutrin XL (bupropion hydrochloride extended-release tablets)

2006D-0083	Draft Guidance for Industry on Clinical Data Needed to Support the Licensure of Trivalent Inactivated Influenza Vaccines

2006P-0241	Appeal District Court Civil Action No. 05-1838 (RWR) and deny the citzen petitions of Ivax and Ranbaxy

2006V-0153	Variance for Hair Removal System

1988N-0242	Hydrocortisone Acetate/Pramoxine HCL/Opportunity/Hearing

WDL 1	Pfizer, Inc.	Vol #:	1

1997S-0162	30-Day Structure Function Claim Notification Letters Dietary

LET 17849	Seven Seas Limited	Vol #:	164

LET 17850	McLind Corporation	Vol #:	164

LET 17851	McLind Corporation	Vol #:	164

LET 17852	McLind Corporation	Vol #:	164

LET 17853	McLand Corporation	Vol #:	164

LET 17854	McLind Corporation	Vol #:	164

LET 17855	I.T. B. S. Corporation	Vol #:	164

LET 17856	Beulah Land Corporation	Vol #:	164

LET 17857	Beulah Land Corporation	Vol #:	164

LET 17858	Beulah Land Corporation	Vol #:	164

LET 17859	Beulah Land Corporation	Vol #:	164

LET 17860	Beulah Land Corporation	Vol #:	164

LET 17861	Beulah Land Corporation	Vol #:	164

LET 17862	Beulah Land Corporation	Vol #:	164

LET 17863	Beulah Land Corporation	Vol #:	164

LET 17864	Beulah Land Corporation	Vol #:	164

LET 17865	Beulah land Corporation	Vol #:	164

LET 17866	Beulah Land Corporation	Vol #:	164

LET 17867	Beulah Land Corporation	Vol #:	164

LET 17868	Beulah Land Corporation	Vol #:	164

LET 17869	Marion A. Hauser	Vol #:	164

LET 17870	Beulah Land Corporation	Vol #:	164

LET 17871	Beulah Land Corporation	Vol #:	164



LET 17872	Beulah Land Corporation	Vol #:	164

LET 17873	Beulah Land Corporation	Vol #:	164

LET 17874	Beulah Land Corporation	Vol #:	164

LET 17875	Beulah Land Corporation	Vol #:	164

LET 17876	Beulah Land Corporation	Vol #:	164

LET 17877	Pure Encapsulations	Vol #:	164

1998P-0151	Introduction Of Downed Cattle Into The Food Supply

C 7529	C. Ciliberti	Vol #:	319

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

C 12334	D. Melete	Vol #:	151

C 12335	E. Jessie	Vol #:	151

C 12336	D. Maniscako	Vol #:	151

C 12337	S. O'Dell	Vol #:	151

C 12338	P. Pattyn	Vol #:	151

C 12339	Y. Calderon	Vol #:	151

C 12340	N. C. Ramos	Vol #:	151

C 12341	G. O'Hara	Vol #:	151

C 12342	F. Disquz	Vol #:	151

C 12343	M. L. Miller	Vol #:	151

C 12344	L. Walter	Vol #:	151

C 12345	M. Goldmunz	Vol #:	151

C 12346	K. Bajus	Vol #:	151

C 12347	J. Bauer	Vol #:	151

C 12348	T. J. Miller	Vol #:	151

C 12349	J. Harris	Vol #:	151

C 12350	T. Kenswortkey	Vol #:	151

C 12351	T. Kenswortkey	Vol #:	151

C 12352	P. Ciarrosshi	Vol #:	151

C 12353	D. Fcnho	Vol #:	151

C 12354	A. A. Cherny	Vol #:	151

C 12355	C. Oker	Vol #:	151

C 12356	G. Pearson	Vol #:	151

C 12357	G. O'haro	Vol #:	151

C 12358	J. Dries	Vol #:	151

C 12359	B. Kalmback	Vol #:	151



C 12360	G O'Hara	Vol #:	151

C 12361	L. Fischer	Vol #:	151

C 12362	M Vinu	Vol #:	151

C 12363	L. Marle	Vol #:	151

C 12364	L. Marie	Vol #:	151

C 12365	N. Lewis	Vol #:	151

C 12366	D. McCarthy	Vol #:	151

C 12367	K Bajus	Vol #:	151

C 12368	J. Coffery	Vol #:	151

C 12369	L. Johnson	Vol #:	151

C 12370	V. Tream	Vol #:	151

C 12371	H. Whithey	Vol #:	151

C 12372	P. Bakatsas	Vol #:	151

C 12373	K Currie	Vol #:	151

C 12374	Joy Simon	Vol #:	151

C 12375	L. Wihels	Vol #:	151

C 12376	G. O'Hara	Vol #:	151

C 12377	W. Devenney	Vol #:	151

C 12378	T. Snelson	Vol #:	151

C 12379	C. Wolstrnhone	Vol #:	151

C 12380	C. Young	Vol #:	151

C 12381	A. Illingwolf	Vol #:	151

C 12382	P. Stfinfrt	Vol #:	151

C 12383	S. Phillips	Vol #:	151

C 12384	L. Davie	Vol #:	151

C 12385	R. Wilson	Vol #:	151

C 12386	Susann	Vol #:	151

C 12387	M. A Ilbert	Vol #:	151

C 12388	D. Parrish	Vol #:	151

C 12389	C. Niclcol	Vol #:	151

C 12390	L. Johnson	Vol #:	151

C 12391	E. Tirsley	Vol #:	151

C 12392	S. Tirsley	Vol #:	151

C 12393	S. Phillips	Vol #:	151

C 12394	C. Bookshft	Vol #:	151

C 12395	J. C Heghtion	Vol #:	151

C 12396	D. O'Mara	Vol #:	151



C 12397	M. Ziegler	Vol #:	151

C 12398	G. Barsamin	Vol #:	151

C 12399	J. Siegner	Vol #:	151

C 12400	S. Emerson	Vol #:	151

C 12401	C. Chase	Vol #:	151

C 12402	P. Jarnett	Vol #:	151

C 12403	S. Wood	Vol #:	151

C 12404	S. J. Rose	Vol #:	151

C 12405	B. Galvan	Vol #:	151

C 12406	R. S. Johnson	Vol #:	151

C 12407	V. Wense	Vol #:	151

C 12408	B. L. Hanson	Vol #:	151

C 12409	V. Wense	Vol #:	151

C 12410	P. A. Kelly	Vol #:	151

C 12411	K. Peterson	Vol #:	151

C 12412	S. Mckinnon	Vol #:	151

C 12413	A.M. Spiliotis	Vol #:	151

C 12414	P. Molinar	Vol #:	151

C 12415	S. Marchett	Vol #:	151

C 12416	A.A. Bendxen-Chern	Vol #:	151

C 12417	T. A. Klenske	Vol #:	151

C 12418	D. Kastenbarn	Vol #:	151

C 12419	D. Olson	Vol #:	151

C 12420	J. Wiley	Vol #:	151

C 12421	B. Mignosi	Vol #:	151

C 12422	B. Timpone	Vol #:	151

C 12423	J.Brown	Vol #:	151

C 12424	P. Garvic	Vol #:	151

C 12425	L. Walls	Vol #:	151

C 12426	J. James	Vol #:	151

C 12427	J. MorveLandgneu	Vol #:	151

C 12428	C.Morren	Vol #:	151

C 12429	L. L. Burn	Vol #:	151

C 12430	J. Christionson	Vol #:	151

C 12431	C. A. Hewith	Vol #:	151

C 12432	S.Fisker	Vol #:	151

C 12433	T. Allender	Vol #:	151



C 12434	S. Peery	Vol #:	151

C 12435	L. Cianchetta	Vol #:	151

C 12436	S. Trammell	Vol #:	151

C 12437	S. Trammell	Vol #:	151

C 12438	J. S. Pleeka	Vol #:	151

C 12439	C. Miller	Vol #:	151

C 12440	R. Nabring	Vol #:	151

C 12441	D. Count	Vol #:	151

C 12442	S. Chapin	Vol #:	151

C 12443	L. Krenzer	Vol #:	151

C 12444	N. Hunter	Vol #:	151

C 12445	D. Bowman	Vol #:	151

C 12446	A. Murray	Vol #:	151

C 12447	M. Merrill	Vol #:	151

C 12448	S. Matson	Vol #:	151

C 12449	S. Matson	Vol #:	151

C 12450	B. Hawwink-McElunn	Vol #:	151

C 12451	T. R. Turner	Vol #:	151

C 12452	B. J. Popiel	Vol #:	151

C 12453	S. M. Doerr	Vol #:	151

C 12454	L. Moor	Vol #:	151

C 12455	T. Hoto	Vol #:	151

C 12456	T. R. Turner	Vol #:	151

C 12457	Ms. W. Stclair	Vol #:	151

C 12458	C. Sanders	Vol #:	151

C 12459	P. E. Gleason	Vol #:	151

C 12460	Mrs. M. Tripp	Vol #:	151

C 12461	B. Bestick	Vol #:	151

C 12462	W. J. Schwegel	Vol #:	151

C 12463	A. Rollings	Vol #:	151

C 12464	Ms. P. Wilt	Vol #:	151

C 12465	Ms. D. Hancock	Vol #:	151

C 12466	C. Leonard	Vol #:	151

C 12467	D. J. Eyman	Vol #:	151

C 12468	G. Cruz	Vol #:	151

C 12469	M. L. Mershon	Vol #:	151

C 12470	D. K. Morasco	Vol #:	151



C 12471	M. Halliday	Vol #:	151

C 12472	P. Morales	Vol #:	151

C 12473	Mrs. C. Dalgleish	Vol #:	151

C 12474	M. Mastro	Vol #:	151

C 12475	H. Gurnee	Vol #:	151

C 12476	Mrs. G. Holter	Vol #:	151

C 12477	J, Chilcote	Vol #:	151

C 12478	E. Crawford	Vol #:	151

C 12479	B. J. Renshaw	Vol #:	151

C 12480	S.M. Schmidt	Vol #:	151

C 12481	A. Kurtz Vogt	Vol #:	151

C 12482	M. Broown	Vol #:	151

C 12483	B. Praiswater	Vol #:	151

2005P-0493	Establish criteria, analogous to the criteria for marketing Category I drug products under OTC Drug Review regarding the substitutability of prescription hyoscyamine drug products

LET 1	FDA/CDER to Buchanan Ingersoll PC	Vol #:	1

2005P-0498	Criteria of generic version of Wellbutrin XL (bupropion hydrochloride extended-release tablets)

LET 1	FDA/CDER to Keller and Heckman LLP	Vol #:	1

2006D-0083	Draft Guidance for Industry on Clinical Data Needed to Support the Licensure of Trivalent Inactivated Influenza Vaccines

C 4	Sanofi Pasteur, Inc	Vol #:	1

2006P-0241	Appeal District Court Civil Action No. 05-1838 (RWR) and deny the citzen petitions of Ivax and Ranbaxy

ACK 1	FDA/DDM to Zydus Pharmaceuticals Inc	Vol #:	1

2006V-0153	Variance for Hair Removal System
VRA 1	FDA/CDRH to Palomar Medical Technologies, Inc.	Vol #:	1

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FDA/Dockets Management