Dockets Entered on June 14, 2006


Dockets Management
	Dockets Entered On June 14, 2006 Table of Contents



	Docket #	Title

	1988N-0258	Prescription Drug Marketing Act of 1987; Guideline

	1992N-0297	Prescription Drug Marketing Act of 1987, Drug Amds of 1992

	1998N-1109	Mercury Compounds in Drugs and Food

	2000N-1269	Labeling for human prescription drug/Biologic Products

	2002E-0100	Patent Application for Dutrasteride

	2005P-0406	Benzphetamine Hydrochloride Capsule, 50 mg drug product is suitable for submission as an ANDA

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Drug Marketing Act Pedigree Requirements under 21 CFR Part 203; Effective Date and Compliance Policy GuideProgram, Draft Guidance; Availability

	2006E-0042	Patent Extension Application for CUBICIN (daptomycin for injection), U.S. Patent No. 4,885,243

	2006FL-0238	Food Allergen Labeling Petition (FALP): Culture Media with Enzyme-Treated Soy Solids

	2006N-0133	Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Evaluation of Variations in Content and Format of the Brief Summary in Direct-to-Consumer (DTC) Print Adver

	2006P-0245	Exclusivity Determination for Risperidone

	1988N-0258	Prescription Drug Marketing Act of 1987; Guideline

	NFR 4	FDA	Vol #:	6

	1992N-0297	Prescription Drug Marketing Act of 1987, Drug Amds of 1992

	NFR 5	FDA	Vol #:	10

	1998N-1109	Mercury Compounds in Drugs and Food

	LET 6	Howard Rice Nemerovski Canady Falk & Rabkin	Vol #:	2

	LST 5	Mercury in Drug and Biologic Products List - Update	Vol #:	2

	2000N-1269	Labeling for human prescription drug/Biologic Products

	ANS 1	FDA/OES to National Medical Association	Vol #:	1

	C 85	National Medical Association	Vol #:	1

	2002E-0100	Patent Application for Dutrasteride

	N 1	FDA	Vol #:	1

	2005P-0406	Benzphetamine Hydrochloride Capsule, 50 mg drug product is suitable for submission as an ANDA

	SUP 1	Lachman Consultant Services, 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 12654	J. P. Tofte	Vol #:	152

	C 12655	B. R. Scott	Vol #:	152

	C 12656	M.C. Oty	Vol #:	152

	C 12657	E. Hunt	Vol #:	152



C 12658	J. Tofte	Vol #:	152

C 12659	P. A. Potts	Vol #:	152

C 12660	C. Klebba	Vol #:	152

C 12661	M. E. Pose	Vol #:	152

C 12662	K. Conner	Vol #:	152

C 12663	B. Lewis	Vol #:	152

C 12664	C. Fisher	Vol #:	152

C 12665	C. L. Olsen	Vol #:	152

C 12666	B. C. Cook	Vol #:	152

C 12667	N. Strong	Vol #:	152

C 12668	D. McDowell	Vol #:	152

C 12669	V. Sommers	Vol #:	152

C 12670	A. L. Wiesner	Vol #:	152

C 12671	D. Norber	Vol #:	152

C 12672	L. Harbour	Vol #:	152

C 12673	J. L. Schneider	Vol #:	152

C 12674	A. Petty	Vol #:	152

C 12675	L. Robar	Vol #:	152

C 12676	J. R. Hartman, M.D.	Vol #:	152

C 12677	M. Hall	Vol #:	152

C 12678	C. Hester	Vol #:	152

C 12679	D. Stark	Vol #:	152

C 12680	M. Seymour	Vol #:	152

C 12681	K. Ford	Vol #:	152

C 12682	T. Morse	Vol #:	152

C 12683	L. Rosenthal	Vol #:	152

C 12684	G. L. Honeysett	Vol #:	152

C 12685	P. Smithson	Vol #:	152

C 12686	D. Daniel	Vol #:	152

C 12687	J. O'Neal	Vol #:	152

C 12688	S. Hendricks	Vol #:	152

C 12689	K. Oldaker	Vol #:	152

C 12690	S. Akel	Vol #:	152

C 12691	D. Oliver	Vol #:	152

C 12692	T. Dallas	Vol #:	152

C 12693	Terri Yu	Vol #:	152

C 12694	T. Yu	Vol #:	152



C 12695	C. Bailey	Vol #:	152

C 12696	C. Lahti	Vol #:	152

C 12697	H. Coelho	Vol #:	152

C 12698	V. Fisher	Vol #:	152

C 12699	K. Robinson	Vol #:	152

C 12700	L. Bushouse	Vol #:	152

C 12701	C. Hiller	Vol #:	152

C 12702	C. Hinman	Vol #:	152

C 12703	A. Stanley	Vol #:	152

C 12704	D. Zechmann	Vol #:	152

C 12705	M. Missroon	Vol #:	152

C 12706	M. Cole	Vol #:	152

C 12707	D. S. Gramlich,M.D.	Vol #:	152

C 12708	K. Ogden	Vol #:	152

C 12709	D. Hall	Vol #:	152

C 12710	S. J. Cassady	Vol #:	152

C 12711	T. Fister	Vol #:	152

C 12712	S. Twigg	Vol #:	152

C 12713	L. Brown	Vol #:	152

C 12714	C. H. Bronson	Vol #:	152

C 12715	B. S. Hoots	Vol #:	152

C 12716	J. Aalberts	Vol #:	152

C 12717	J. Farnsworth	Vol #:	152

C 12718	M. Morse	Vol #:	152

C 12719	B. Kane	Vol #:	152

C 12720	K. A. Lary	Vol #:	152

C 12721	A. Adams	Vol #:	152

C 12722	T. Brulotte	Vol #:	152

C 12723	B. Brulotte	Vol #:	152

C 12724	N. Montgomery	Vol #:	152

C 12725	D. Zienkovicz	Vol #:	152

C 12726	M. Damon	Vol #:	152

C 12727	J. Jolcuvar	Vol #:	152

C 12728	R. M. Jaimez-Price	Vol #:	152

C 12729	C. Goldstein	Vol #:	152

C 12730	J. Steen	Vol #:	152

C 12731	D. Edmondson	Vol #:	152



C 12732	J. Biesboer	Vol #:	152

C 12733	L. Harper	Vol #:	152

C 12734	J. Thayer	Vol #:	152

C 12735	M. Baichi	Vol #:	152

C 12736	L. Giraidi	Vol #:	152

C 12737	K. Coleman	Vol #:	152

C 12738	C. Whitman	Vol #:	152

C 12739	B. Jones	Vol #:	152

C 12740	S. Armstrong	Vol #:	152

C 12741	E. A. Folkerth	Vol #:	152

C 12742	J. Bibby	Vol #:	152

C 12743	J. Wright	Vol #:	152

C 12744	J. Cullan	Vol #:	152

C 12745	D. A. Meier	Vol #:	152

C 12746	Nancy L. Corbin	Vol #:	152

C 12747	Dr. K. Willis	Vol #:	152

C 12748	C. Rinkel	Vol #:	152

C 12749	C. L. Payne	Vol #:	152

C 12750	C. Hoffacker	Vol #:	152

C 12751	W. Wilson	Vol #:	152

C 12752	H. K. Braaten	Vol #:	152

C 12753	D. A. Foreman	Vol #:	152

C 12754	V. Durham	Vol #:	152

C 12755	S. Swanson	Vol #:	152

C 12756	R. A. Rons	Vol #:	152

C 12757	K. Greenwald	Vol #:	152

C 12758	Dr. C. Garcia	Vol #:	152

C 12759	L. Iverson	Vol #:	152

C 12760	M. Brose	Vol #:	152

C 12761	Ms. L. Wolschlager	Vol #:	152

C 12762	S. Whitney	Vol #:	152

C 12763	S. S. Jacobs	Vol #:	152

C 12764	J. Bonney and S. Bonney	Vol #:	152

C 12765	Ms. S. Haines	Vol #:	152

C 12766	K. Fowler	Vol #:	152

C 12767	Ms. M. Mahoney	Vol #:	152

C 12768	Ms. J. M. Schroeder	Vol #:	152



C 12769	J. Shirreffs and P. Barnett	Vol #:	152

C 12770	T. Beall	Vol #:	152

C 12771	K. A. Stanton	Vol #:	152

C 12772	A. Crutcher	Vol #:	152

C 12773	Mrs. M. Genso	Vol #:	152

C 12774	R. Perez	Vol #:	153

C 12775	J. Hershman	Vol #:	153

C 12776	E. Wilson	Vol #:	153

C 12777	P. Straw	Vol #:	153

C 12778	Mrs. A. H. Campbell	Vol #:	153

C 12779	D. Sampier	Vol #:	153

C 12780	Mrs. L. Buffa	Vol #:	153

C 12781	C. Schmidt	Vol #:	153

C 12782	B. Zinner	Vol #:	153

C 12783	L. Browning	Vol #:	153

C 12784	G. Klaber and A. Klaber	Vol #:	153

C 12785	M. Ulrych	Vol #:	153

C 12786	A. Amaral	Vol #:	153

C 12787	S. Nakaya	Vol #:	153

C 12788	G. Merten	Vol #:	153

C 12789	L. Weller	Vol #:	153

C 12790	H. C. Wilson	Vol #:	153

C 12791	K. A. Price	Vol #:	153

C 12792	J. Barnes	Vol #:	152

C 12793	Ms. M. Morgan	Vol #:	153

C 12794	M. Lucas	Vol #:	153

C 12795	P.Brandon	Vol #:	153

C 12796	P. Adams	Vol #:	153

C 12797	D. La Valley	Vol #:	153

C 12798	S. Mattson	Vol #:	153

C 12799	D. A. Franklin	Vol #:	153

C 12800	F. Petronzio	Vol #:	153

C 12801	E. Pate	Vol #:	153

C 12802	Ms. S. M. McDonald	Vol #:	153

C 12803	O. Dabbs	Vol #:	153

C 12804	K. Schrupp	Vol #:	153

C 12805	L. Garcia	Vol #:	153



C 12806	P. Adams	Vol #:	153

C 12807	H. Geraci	Vol #:	153

C 12808	D. S. Meyer	Vol #:	153

C 12809	S. Henderson	Vol #:	153

C 12810	C. Stiefel	Vol #:	153

C 12811	B. M. Border	Vol #:	153

C 12812	C. Huelsmann	Vol #:	153

C 12813	F. Womack	Vol #:	153

C 12814	C. Lawrence	Vol #:	153

C 12815	B. Rosenshein	Vol #:	153

C 12816	F. Tablas	Vol #:	153

C 12817	J. A. Levin	Vol #:	153

C 12818	M. Bolton	Vol #:	153

C 12819	L. Schlenker	Vol #:	153

C 12820	J. Sussman	Vol #:	153

C 12821	P. Carlstrom	Vol #:	153

C 12822	D. Duncan	Vol #:	153

C 12823	M. Davenport	Vol #:	153

C 12824	J. Duree	Vol #:	153

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

NAD 1	FDA	Vol #:	1

2006E-0042	Patent Extension Application for CUBICIN (daptomycin for injection), U.S. Patent No. 4,885,243

N 1	FDA	Vol #:	1

2006FL-0238	Food Allergen Labeling Petition (FALP): Culture Media with Enzyme-Treated Soy Solids

CP 1	International Media and Cultures (IMAC)	Vol #:	1

2006N-0133	Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Evaluation of Variations in Content and Format of the Brief Summary in Direct-to- Consumer (DTC) Print Adver


C 2	13 signatures	Vol #:	1

2006P-0245	Exclusivity Determination for Risperidone

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

CP 1	Mylan Pharmaceuticals, Inc.	Vol #:	1

Page created on July 18, 2006 kk

FDA/Dockets Management