Dockets Entered on July 25, 2006


Dockets Management
	Dockets Entered On July 25, 2006 Table of Contents



	Docket #	Title

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

	1999P-1340	Declared Eternity eau de Parfum Misbranded

	2002N-0273	Animal Proteins Prohibited in Ruminant Feed

	2004E-0393	Patent Extension for Uroxatral (Alfuzosin hydrochloride), U.S. Patent No. 4,661,491

	2004E-0444	Patent Extension for BONIVA (ibandronate), U.S. Patent No. 4,927,814

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

	2006P-0071	513 (e) Reclassification of Tissue Adhesive For Soft Tissue Approximation

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

	2006P-0205	Require Vitamin D be added to cereal-grain products

	2006P-0223	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

	2006P-0291	Determine whether Eloxatin (Oxaliplatin has been voluntarily withdrawn or withheld from sale for safety or efficacy reasons

	2006P-0298	To permit an ANDA Suitability for Eloxatin (Oxaliplatin for injection)

	2006P-0299	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whether Eloxatin (Oxaliplatin for Injection) 50 mg and 100 mg sterile lyophilized powder vials (NDA #21-492 has been withdrawn for safety or effectiveness reasons

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

	C 7530	M Lukasiewicz	Vol #:	319

	1999P-1340	Declared Eternity eau de Parfum Misbranded

	C 761	L Hamilton	Vol #:	21

	2002N-0273	Animal Proteins Prohibited in Ruminant Feed

	C 539	United State Senate	Vol #:	45

	2004E-0393	Patent Extension for Uroxatral (Alfuzosin hydrochloride), U.S. Patent No. 4,661,491

	N 1	FDA	Vol #:	1

	2004E-0444	Patent Extension for BONIVA (ibandronate), U.S. Patent No. 4,927,814

	C 1	Hoffmann-La Roche Inc	Vol #:	1

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

	C 17007	M. Reese	Vol #:	188

	C 17008	T. Snow	Vol #:	188

	C 17009	K. Sweeney	Vol #:	188

	C 17010	S. Bass	Vol #:	188

	C 17011	A. McKane	Vol #:	188

	C 17012	S. Shrauger	Vol #:	188

	C 17013	D. Troxell	Vol #:	188

	C 17014	M. Citrano	Vol #:	188



C 17015	M. Gill	Vol #:	188

C 17016	V. Burke	Vol #:	188

C 17017	W. Langston	Vol #:	188

C 17018	P. Askew	Vol #:	188

C 17019	D. Heizer	Vol #:	188

C 17020	P. Lindley	Vol #:	188

C 17021	J. Slclcnka	Vol #:	188

C 17022	M. Wilke	Vol #:	188

C 17023	K. Hartman	Vol #:	188

C 17024	M. Luongo	Vol #:	188

C 17025	J. Jaeian	Vol #:	188

C 17026	G. Fowler	Vol #:	188

C 17027	J. Reitler	Vol #:	188

C 17028	A. Robinson	Vol #:	188

C 17029	P. Krause	Vol #:	188

C 17030	E. Johnson	Vol #:	188

C 17031	C. Morera	Vol #:	188

C 17032	D. Lewis	Vol #:	188

C 17033	M. Keal	Vol #:	188

C 17034	A. Johnson	Vol #:	188

C 17035	E. Acuna	Vol #:	188

C 17036	M. Hyatt	Vol #:	188

C 17037	A. Johnson	Vol #:	188

C 17038	A. Tyrrell	Vol #:	188

C 17039	I. Tyrrell	Vol #:	188

C 17040	S. Luerssen	Vol #:	188

C 17041	A. Saare	Vol #:	188

C 17042	J. Dominick	Vol #:	188

C 17043	C. McCall	Vol #:	188

C 17044	J. Maeda	Vol #:	188

C 17045	R. Hangini	Vol #:	188

C 17046	Illegible	Vol #:	188

C 17047	B. Smith	Vol #:	188

C 17048	L. Ellsworth	Vol #:	188

C 17049	K. Zarnar	Vol #:	188

C 17050	J. Swan	Vol #:	188

C 17051	D. Galster	Vol #:	188



C 17052	S. Banko	Vol #:	188

C 17053	K. Miller	Vol #:	188

C 17054	J. Huff	Vol #:	188

C 17055	M. Dessureault	Vol #:	188

C 17056	J. McGlynn	Vol #:	188

C 17057	B. Hershey	Vol #:	188

C 17058	G. Franco	Vol #:	188

C 17059	G. Konn	Vol #:	188

C 17060	Z. Hershey	Vol #:	188

C 17061	K. Morefield-Fingal	Vol #:	188

C 17062	M. Connelly	Vol #:	188

C 17063	J. Miklasz	Vol #:	188

C 17064	S. Racanelli	Vol #:	188

C 17065	K. Matrille	Vol #:	188

C 17066	R. Plett	Vol #:	188

C 17067	J. Welch	Vol #:	188

C 17068	B. Miller	Vol #:	188

C 17069	P. Bowman	Vol #:	188

C 17070	P. Bjeurjac	Vol #:	188

C 17071	C. Kelly	Vol #:	188

C 17072	B. Ladner-Fridley	Vol #:	188

C 17073	L. Snyder	Vol #:	188

C 17074	C. Rose	Vol #:	188

C 17075	P. Thompson	Vol #:	188

C 17076	D. Broder	Vol #:	188

C 17077	D. Librans	Vol #:	188

C 17078	B. Persing	Vol #:	188

C 17079	J. Beeson	Vol #:	188

C 17080	M. Scherf	Vol #:	188

C 17081	R. Monely	Vol #:	188

C 17082	K. Erickson	Vol #:	188

C 17083	C. Scherf-Ghara	Vol #:	188

C 17084	P. Stanley	Vol #:	188

C 17085	C. Coseatino	Vol #:	188

C 17086	M. Gehringer	Vol #:	188

C 17087	M. Harrison	Vol #:	188

C 17088	B. Belohovek	Vol #:	188



C 17089	A. Fleming	Vol #:	188

C 17090	M. Zuziak	Vol #:	188

C 17091	M. Bright	Vol #:	188

C 17092	P. Easley	Vol #:	188

C 17093	C. Platt	Vol #:	188

C 17094	W. Bradley	Vol #:	188

C 17095	B. Reynolds	Vol #:	188

C 17096	W. Taylor	Vol #:	188

C 17097	J. Lindsey	Vol #:	188

C 17098	M. Sherman	Vol #:	188

C 17099	E. Martin	Vol #:	188

C 17100	M. White	Vol #:	188

C 17101	M. Nicolai	Vol #:	188

C 17102	P. Parkhurst	Vol #:	188

C 17103	D. Keenan	Vol #:	188

C 17104	C. Moore	Vol #:	188

C 17105	N. Vasquez	Vol #:	188

C 17106	N. Metoyer	Vol #:	188

C 17107	J. Ramos	Vol #:	188

C 17108	E. Cervera	Vol #:	188

C 17109	J. Mendoza	Vol #:	188

C 17110	C. Morales	Vol #:	188

C 17111	B. Hernandez	Vol #:	188

C 17112	R. Johnson	Vol #:	188

C 17113	D. Krueger	Vol #:	188

C 17114	L. Scarcello	Vol #:	188

C 17115	L. Koessl	Vol #:	188

C 17116	B. Norman	Vol #:	188

C 17117	J. Russo	Vol #:	188

C 17118	K. Dalton	Vol #:	188

C 17119	G. McDonald	Vol #:	188

C 17120	D. Sims	Vol #:	188

C 17121	J. Enzenbacher	Vol #:	188

C 17122	P. English	Vol #:	188

C 17123	S. Shun	Vol #:	188

C 17124	A. Suran	Vol #:	188

C 17125	S. Wait	Vol #:	188



C 17126	C. Hilger	Vol #:	188

C 17127	S. Garneill	Vol #:	188

C 17128	A. Millwee	Vol #:	188

C 17129	K. Gonzales	Vol #:	188

C 17130	S. Dulka	Vol #:	188

C 17131	A. Buddemeier	Vol #:	188

C 17132	C. Day	Vol #:	188

C 17133	V. Foxworth	Vol #:	188

C 17134	E. Gibbs	Vol #:	188

C 17135	R. Muro	Vol #:	188

C 17136	L. Alexander	Vol #:	188

C 17137	C. Ryan	Vol #:	188

C 17138	C. Howell	Vol #:	188

C 17139	M. Luongo	Vol #:	188

C 17140	P. Johnson	Vol #:	188

C 17141	N. Neilsen	Vol #:	188

C 17142	M. Cooper	Vol #:	188

C 17143	C. Venezia	Vol #:	188

C 17144	C. Stemp	Vol #:	188

C 17145	S. Inns	Vol #:	188

C 17146	T. Uhl	Vol #:	188

C 17147	D. Querner	Vol #:	188

C 17148	J. Collani	Vol #:	188

C 17149	D. Tavakkoly	Vol #:	188

C 17150	D. Logan	Vol #:	188

C 17151	P. Rosol	Vol #:	188

C 17152	P. Rosol	Vol #:	188

C 17153	J. Cobe	Vol #:	188

C 17154	Y. Smith	Vol #:	188

C 17155	G. Long	Vol #:	188

C 17156	D. Juhl	Vol #:	188

C 17157	C. Neuendorff	Vol #:	188

C 17158	K. Tesorero	Vol #:	188

C 17159	P. Bowman	Vol #:	188

C 17160	T. Goodwin	Vol #:	188

C 17161	W. Hwang	Vol #:	188

C 17162	J. Chilenko	Vol #:	188



C 17163	S. Tripp	Vol #:	188

C 17164	V. Johnson	Vol #:	188

C 17165	V. Pena	Vol #:	188

C 17166	D. Maltby	Vol #:	188

C 17167	L. Venarrzi	Vol #:	188

C 17168	P. Mohns	Vol #:	188

C 17169	C. Peck	Vol #:	188

C 17170	F. Azimi	Vol #:	188

C 17171	L. Steave	Vol #:	188

C 17172	D. Ray	Vol #:	188

C 17173	D. Haley	Vol #:	188

C 17174	M. Mittalstagnt	Vol #:	188

C 17175	A. Rose	Vol #:	188

C 17176	S. Demartino	Vol #:	188

C 17177	L. Giese	Vol #:	189

C 17178	L. Quintana	Vol #:	189

C 17179	M. Allen	Vol #:	189

C 17180	N. Nelson	Vol #:	189

C 17181	S. Howser	Vol #:	189

C 17182	P. Derr	Vol #:	189

C 17183	J. Burkhardt	Vol #:	189

C 17184	D. Werner	Vol #:	189

C 17185	J. Hammonds	Vol #:	189

C 17186	E. Linkner	Vol #:	189

C 17187	J. Bacon	Vol #:	189

C 17188	K. Segerson	Vol #:	189

C 17189	S. Van Sluis	Vol #:	189

C 17190	L. Cherri	Vol #:	189

C 17191	M. Bowers	Vol #:	189

C 17192	M. Sontoson	Vol #:	189

C 17193	P. Gonzalez	Vol #:	189

C 17194	F. Ramos	Vol #:	189

C 17195	T. Kimpel	Vol #:	189

C 17196	D. Guerra	Vol #:	189

C 17197	R. Hall	Vol #:	189

C 17198	L. Cheatham	Vol #:	189

C 17199	R. Nash	Vol #:	189



C 17200	V. Armstrong	Vol #:	189

C 17201	D. Lura	Vol #:	189

C 17202	J. Griffith	Vol #:	189

C 17203	S. Griffith	Vol #:	189

C 17204	C. Hagen	Vol #:	189

C 17205	M. Younger	Vol #:	189

C 17206	J. Hammonds	Vol #:	189

C 17207	B. Shutt	Vol #:	189

C 17208	B. Shutt	Vol #:	189

C 17209	C. Burgeos	Vol #:	189

C 17210	V. Dixon	Vol #:	189

C 17211	T. Driggers	Vol #:	189

C 17212	C. Cox	Vol #:	189

C 17213	M. Denicola	Vol #:	189

C 17214	J. Pietrowsky	Vol #:	189

C 17215	S. Will	Vol #:	189

C 17216	A. Jackson	Vol #:	189

C 17217	D. diCisare	Vol #:	189

C 17218	K. Maibach	Vol #:	189

C 17219	L. Feldman	Vol #:	189

C 17220	V. Maks	Vol #:	189

C 17221	P. Patterson	Vol #:	189

C 17222	C. Carra	Vol #:	189

C 17223	N. Morici	Vol #:	189

C 17224	E. Kaylor	Vol #:	189

C 17225	R. Chmura	Vol #:	189

C 17226	K. Smith	Vol #:	189

C 17227	S. Fleming	Vol #:	189

C 17228	E. Field	Vol #:	189

C 17229	R. Turoff	Vol #:	189

C 17230	M. Benner	Vol #:	189

C 17231	C. Anderson	Vol #:	189

C 17232	J. Weatherford	Vol #:	189

C 17233	M. Smith	Vol #:	189

C 17234	L. Haines	Vol #:	189

C 17235	B. Lederman	Vol #:	189

C 17236	C. Reding	Vol #:	189



C 17237	B. Lamb	Vol #:	189

C 17238	P. Meyers	Vol #:	189

C 17239	D. Delgado	Vol #:	189

C 17240	D. Rodriquez	Vol #:	189

C 17241	D. Novak	Vol #:	189

C 17242	A. MacCallum	Vol #:	189

C 17243	M. Toler	Vol #:	189

C 17244	C. de la Fuente	Vol #:	189

C 17245	N. Verhei	Vol #:	189

C 17246	J. Wilson	Vol #:	189

C 17247	G. Parra	Vol #:	189

C 17248	N. Garnard-Moricori	Vol #:	189

C 17249	K. Peschke	Vol #:	189

C 17250	L. Liem	Vol #:	189

C 17251	V. Papin	Vol #:	189

C 17252	C. Moore	Vol #:	189

C 17253	L. Cherri	Vol #:	189

C 17254	B. Leptowski	Vol #:	189

C 17255	K. Fletcher	Vol #:	189

C 17256	F. Fernandez	Vol #:	189

C 17257	M. Palmatier	Vol #:	189

C 17258	D. Fallon	Vol #:	189

C 17259	G. Rice	Vol #:	189

C 17260	C. Peery	Vol #:	189

C 17261	T. Adams	Vol #:	189

C 17262	R. Beller	Vol #:	189

C 17263	K. Butler	Vol #:	189

C 17264	J. McCormick	Vol #:	189

C 17265	F. Patino	Vol #:	189

C 17266	P. Calvert	Vol #:	189

C 17267	C. Sierra	Vol #:	189

C 17268	S. Villarreal	Vol #:	189

C 17269	B. Edwards	Vol #:	189

C 17270	J. Colvin	Vol #:	189

C 17271	B. Vaughan	Vol #:	189

C 17272	C. Adams	Vol #:	189

C 17273	J. Jones	Vol #:	189



C 17274	G. Tiborczszeghy	Vol #:	189

C 17275	T. Esparza	Vol #:	189

C 17276	J. Bailey	Vol #:	189

C 17277	C. Thornton	Vol #:	189

C 17278	R. Gross	Vol #:	189

C 17279	S. Guerriero	Vol #:	189

C 17280	J. Petro	Vol #:	189

C 17281	E. Fuller	Vol #:	189

C 17282	H. Farnam	Vol #:	189

C 17283	E. Power	Vol #:	189

C 17284	J. Bernasconi	Vol #:	189

C 17285	V. Bretthauer	Vol #:	189

C 17286	A. Fletcher	Vol #:	189

C 17287	C. Rabaut	Vol #:	189

C 17288	M. Lockhart	Vol #:	189

C 17289	J. Blair	Vol #:	189

C 17290	United States Senate	Vol #:	189

C 17291	United States Senate	Vol #:	189

C 17292	C. Novak	Vol #:	189

C 17293	K. Foster	Vol #:	189

C 17294	T. Garletts	Vol #:	189

C 17295	S. Roberts	Vol #:	189

C 17296	V. Crabb	Vol #:	189

C 17297	S. Good	Vol #:	189

C 17298	E. Cain	Vol #:	189

C 17299	E. Graper	Vol #:	189

C 17300	A. Haag	Vol #:	189

C 17301	V. Cormier	Vol #:	189

C 17302	C. Peterson	Vol #:	189

C 17303	S. Lamley	Vol #:	189

C 17304	M. Martens	Vol #:	189

C 17305	C. Halvorson	Vol #:	189

C 17306	F. Perry	Vol #:	189

C 17307	D. Haserot	Vol #:	189

C 17308	B. Long	Vol #:	189

C 17309	G. Phillips	Vol #:	189

C 17310	S. Brewbaker	Vol #:	189



C 17311	J. Rhodes	Vol #:	189

C 17312	N. Chicon	Vol #:	189

C 17313	B. Baisley	Vol #:	189

C 17314	L. Kitaychik	Vol #:	189

C 17315	R. Perkins	Vol #:	189

C 17316	R. Kay	Vol #:	189

C 17317	L. Martin	Vol #:	189

C 17318	S. Wheeler	Vol #:	189

C 17319	R. Davis	Vol #:	189

C 17320	L. Yarbrough	Vol #:	189

C 17321	M. Joyner	Vol #:	189

C 17322	J. Shapiro	Vol #:	189

C 17323	J. Hickak	Vol #:	189

C 17324	D. Higginbottom	Vol #:	189

C 17325	J. Hickak	Vol #:	189

C 17326	D. Lyons	Vol #:	189

C 17327	B. Christopher	Vol #:	189

C 17328	M. Nevins	Vol #:	189

C 17329	R. Lynch	Vol #:	189

C 17330	L. Juneau	Vol #:	189

C 17331	R. Tam	Vol #:	189

C 17332	P. McKenna	Vol #:	189

C 17333	S. Davis	Vol #:	189

C 17334	K. Fich-Eldridge	Vol #:	189

C 17335	E. Schrank	Vol #:	189

C 17336	P. Wheeler	Vol #:	189

C 17337	S. Haughey	Vol #:	189

C 17338	P. Bailey	Vol #:	189

C 17339	A-M. Lockmyer	Vol #:	189

C 17340	V. Cox	Vol #:	189

C 17341	K. Lamb	Vol #:	189

C 17342	K. Pheney	Vol #:	189

C 17343	K. Ellsworth	Vol #:	189

C 17344	J. Ellsworth	Vol #:	189

C 17345	L. Lee	Vol #:	189

C 17346	V. Shore	Vol #:	189

C 17347	C. Conrad	Vol #:	189



C 17348	B. Kestegian	Vol #:	189

C 17349	H. Stolzenberg	Vol #:	189

C 17350	C. McDermott	Vol #:	190

C 17351	N. Ladbon-Khatibi	Vol #:	190

C 17352	J. Hadsall	Vol #:	190

C 17353	K. Beger	Vol #:	190

C 17354	I. Couture	Vol #:	190

C 17355	E. Roman	Vol #:	190

C 17356	L. Beseda	Vol #:	190

C 17357	R. Wasserman	Vol #:	190

C 17358	D. Collier	Vol #:	190

C 17359	C. Ardito	Vol #:	190

C 17360	N. Lamberti	Vol #:	190

C 17361	L. Tillema	Vol #:	190

C 17362	R. Beller	Vol #:	190

C 17363	P. Williamson	Vol #:	190

C 17364	P. Condon	Vol #:	190

C 17365	L. Koop	Vol #:	190

C 17366	A. Bass	Vol #:	190

C 17367	G. Weitz	Vol #:	190

C 17368	S. Tarbuk	Vol #:	190

C 17369	S. Gordon	Vol #:	190

C 17370	M. Vieck	Vol #:	190

C 17371	R. Gremore	Vol #:	190

C 17372	S. Brandvold	Vol #:	190

C 17373	C. Ginoff	Vol #:	190

C 17374	B. Bellsiegs	Vol #:	190

C 17375	J. Molina	Vol #:	190

C 17376	N. Lisek	Vol #:	190

C 17377	T. Mason	Vol #:	190

C 17378	S. Segerstrom	Vol #:	190

C 17379	C. Rudat	Vol #:	190

C 17380	S. Griffo	Vol #:	190

C 17381	J. Chartier	Vol #:	190

C 17382	T. Barnes	Vol #:	190

C 17383	J. Roberts	Vol #:	190

C 17384	J. Boyack	Vol #:	190



C 17385	K. Boyack	Vol #:	190

C 17386	Illegible	Vol #:	190

C 17387	Illegible	Vol #:	190

C 17388	P. Thompson	Vol #:	190

C 17389	D. Snyder	Vol #:	190

C 17390	I.	Vol #:	190

C 17391	A. Cameron	Vol #:	190

C 17392	L. Fox-Dangano	Vol #:	190

C 17393	C. Webster	Vol #:	190

C 17394	M. Brodrick	Vol #:	190

C 17395	D. Flood	Vol #:	190

C 17396	D. Pierce	Vol #:	190

C 17397	P. Wheeler	Vol #:	190

C 17398	H. Gajdos	Vol #:	190

C 17399	S. Madison	Vol #:	190

C 17400	D. Southerland	Vol #:	190

C 17401	C. Parson	Vol #:	190

C 17402	A. Parson	Vol #:	190

C 17403	M. Moran	Vol #:	190

C 17404	L. Moran	Vol #:	190

C 17405	P. Bailey	Vol #:	190

C 17406	D. Miller	Vol #:	190

C 17407	D. Gloe	Vol #:	190

C 17408	B. Fender	Vol #:	190

C 17409	C. Banville	Vol #:	190

C 17410	P. Gaddle	Vol #:	190

C 17411	M. Wilson	Vol #:	190

C 17412	T. Uriarte	Vol #:	190

C 17413	S. Timmons	Vol #:	190

C 17414	J. & A. Trumbore	Vol #:	190

C 17415	C. Darden	Vol #:	190

C 17416	J. Svenson	Vol #:	190

C 17417	J. Reich	Vol #:	190

C 17418	F. Vicent	Vol #:	190

C 17419	D. Pendleton	Vol #:	190

C 17420	G. Auteri	Vol #:	190

C 17421	C. Campbell	Vol #:	190



C 17422	R. Cater	Vol #:	190

C 17423	S. Cornell	Vol #:	190

C 17424	P. Levien	Vol #:	190

C 17425	S. Shilevich	Vol #:	190

C 17426	J. Alter	Vol #:	190

C 17427	Y. Gooch	Vol #:	190

C 17428	B. O'Connell	Vol #:	190

C 17429	L. Cherry	Vol #:	190

C 17430	M. Kiger	Vol #:	190

C 17431	A. Scholz	Vol #:	190

C 17432	J. Gordon	Vol #:	190

C 17433	L. King	Vol #:	190

C 17434	B. Parker	Vol #:	190

C 17435	E. Nachom	Vol #:	190

C 17436	S. Coffey	Vol #:	190

C 17437	J. Teel	Vol #:	190

C 17438	K. Fahey	Vol #:	190

C 17439	J. Brambila	Vol #:	190

C 17440	M. Corbin	Vol #:	190

C 17441	T. Hunt	Vol #:	190

C 17442	K. Nadler	Vol #:	190

C 17443	C. Heck	Vol #:	190

C 17444	E. MacDonald	Vol #:	190

C 17445	E. Martin	Vol #:	190

C 17446	S. Tomasik	Vol #:	190

C 17447	P. Nentze	Vol #:	190

C 17448	J. Tennant	Vol #:	190

C 17449	L. Highton	Vol #:	190

C 17450	M. Takagi	Vol #:	190

2006P-0071	513 (e) Reclassification of Tissue Adhesive For Soft Tissue Approximation

AMD 2	Regulatory & Clinical Research Institute, Inc. (RCRI)	Vol #:	2

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

C 1	Consumers Union	Vol #:	1

EC 664	Mrs. Betty Smith	Vol #:	3

EC 665	Ms. Marcia Allina	Vol #:	3



EC 666	Ms. Robin Miller	Vol #:	3

EC 667	Ms. Marie Wolfe	Vol #:	3

2006P-0205	Require Vitamin D be added to cereal-grain products

SUP 1	Rutgers, State University of New Jersey	Vol #:	2

2006P-0223	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



SUP 1	State of Wisconsin, Department of Justice	Vol #:	1

2006P-0291	Determine whether Eloxatin (Oxaliplatin has been voluntarily withdrawn or withheld from sale for safety or efficacy reasons

ACK 1	FDA/ DDM to Sicor Pharmaceuticals, Inc.	Vol #:	1

CP 1	Sicor Pharmaceuticals, Inc.	Vol #:	1

2006P-0298	To permit an ANDA Suitability for Eloxatin (Oxaliplatin for injection)

ACK 1	FDA/ DDM to AAC Consulting Group	Vol #:	1

CP 1	AAC Consulting Group	Vol #:	1

2006P-0299	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

ACK 1	FDA/DDM to Rothwell, Figg, Ernst & Manbeck, P.C.	Vol #:	1

CP 1	Rothwell, Figg, Ernst & Manbeck, P.C.	Vol #:	1

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FDA/Dockets Management