Dockets Entered on March 8, 2005

Dockets Management



Dockets Entered On March 8, 2005 Table of Contents



Docket #	Title

1980N-0208	Biological Products; Bacterial Vaccines and Toxiods

2002P-0243	Require Issuance of Medication Guide for All Statin Drugs

2002P-0244	Warning Statement for All HMG Co-A Reductase Inhibitors

2003H-0432	Civil Money Penalty, Korangy Radiology Associates, PA

2004D-0369	Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use

2004N-0230	Food; Current Good Manufacturing Practice Regulations; Public Meetings

2004P-0379	Determine whether Penthrane inhalation has been voluntarily withdrawn from sale for safety or efficacy reasons

2005P-0096	ANDA 77-421 Loratadine Syrup- Hives relief

1980N-0208	Biological Products; Bacterial Vaccines and Toxiods

C 11	Rollins School of Public Health (Emory University)	Vol #:	142

2002P-0243	Require Issuance of Medication Guide for All Statin Drugs

PDN 1	HFD-001 to Emord & Associates	Vol #:	4

2002P-0244	Warning Statement for All HMG Co-A Reductase Inhibitors

PDN 1	HFD-001 to Emord & Associates	Vol #:	4

2003H-0432	Civil Money Penalty, Korangy Radiology Associates, PA

RBF 2	Korangy Radiology Associates, et al	Vol #:	8

2004D-0369	Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use

C 49	Form Letter count 19	Vol #:	21

C 50	J Connerton	Vol #:	15

C 51	M Trevey	Vol #:	15

C 52	S Weaver + 8 signatures	Vol #:	15

C 53	S Orans + 19 signatures	Vol #:	15

C 54	D Driscoll + 22 signatures	Vol #:	15

C 55	Monsanto Company	Vol #:	15

C 56	P Burchard	Vol #:	15

C 57	C Nelson	Vol #:	15

C 58	K Edwards	Vol #:	15

C 59	M Cruz	Vol #:	15

C 60	R Coriell	Vol #:	15

C 61	Center for Science in the Public Interest (CSPI)	Vol #:	15

C 62	L Lewis	Vol #:	15

C 63	S Flynn	Vol #:	15

C 64	Dr I S Perligieri	Vol #:	15



C 65	S Unze	Vol #:	15

C 66	P Kup	Vol #:	15

C 67	National Food Processors Association (NFPA)	Vol #:	15

C 68	D Penders	Vol #:	15

C 69	P Jain	Vol #:	15

C 70	V Hershey	Vol #:	15

C 71	N Rice	Vol #:	15

C 72	R Lang	Vol #:	15

C 73	M Brelje	Vol #:	15

C 74	Biotechnology Industry Organization	Vol #:	15

C 75	E Strauss	Vol #:	15

C 76	R Hornsby	Vol #:	15

CR 1	Center for Food Safety	Vol #:	15

EMC 1370	M Tucker	Vol #:	18

EMC 1371	Living Resources Company	Vol #:	18

EMC 1372	National Campaign for Sustainable Agriculture	Vol #:	18

EMC 1373	National Campaign for Sustainable Agriculture	Vol #:	18

EMC 1374	T Raymondson	Vol #:	19

EMC 1375	P Matheson	Vol #:	18

EMC 1376	Organic Trade Association	Vol #:	18

EMC 1377	B Avery	Vol #:	18

EMC 1378	C Heath	Vol #:	18

EMC 1379	V Wong	Vol #:	18

EMC 1380	S Trexler	Vol #:	18

EMC 1381	K Wiseman	Vol #:	18

EMC 1382	D Chamagme	Vol #:	18

EMC 1383	University of California, Davis	Vol #:	18

EMC 1384	K Putney	Vol #:	18

EMC 1385	G Shaver	Vol #:	18

EMC 1386	J Fuller	Vol #:	18

EMC 1387	University of California, Davis	Vol #:	18

EMC 1388	M Schonbeck PhD	Vol #:	18

EMC 1389	M Frago	Vol #:	18

EMC 1390	Community Alliance with Family Farmers (CAFF)	Vol #:	18

EMC 1391	K Kauffman	Vol #:	18

EMC 1392	University of California, Davis	Vol #:	18

EMC 1393	R Boettcher	Vol #:	18



EMC 1394	C Blair	Vol #:	18

EMC 1395	L Marselle	Vol #:	18

EMC 1396	National Plains Sustainable Agriculture Society	Vol #:	18

EMC 1397	University California, Davis	Vol #:	18

EMC 1398	D Metivier	Vol #:	18

EMC 1399	J Geis	Vol #:	18

EMC 1400	C Whalen	Vol #:	18

EMC 1401	W Manuel	Vol #:	22

EMC 1402	Beyond Pesticides	Vol #:	22

EMC 1403	R Roxas	Vol #:	22

EMC 1404	L MacKinder	Vol #:	22

EMC 1405	G Bachman	Vol #:	22

EMC 1406	C Jones	Vol #:	22

EMC 1407	Center for Food Safety	Vol #:	22

EMC 1408	K Steinmann	Vol #:	22

EMC 1409	R Vogt	Vol #:	22

EMC 1410	N Miller	Vol #:	22

EMC 1411	K Stumpf	Vol #:	22

EMC 1412	H Kyle	Vol #:	22

EMC 1413	R King	Vol #:	22

EMC 1414	L Clark	Vol #:	22

EMC 1415	P Wilson	Vol #:	22

EMC 1416	J Brickner	Vol #:	22

EMC 1417	T Garner	Vol #:	22

EMC 1418	R Reynolds	Vol #:	22

EMC 1419	S Paltin MD	Vol #:	22

EMC 1420	S Wingrove	Vol #:	22

EMC 1421	S Osborne	Vol #:	22

EMC 1422	M Russell	Vol #:	22

EMC 1423	C Sedotto	Vol #:	22

EMC 1424	C Pettey	Vol #:	22

EMC 1425	J Lefevre	Vol #:	22

EMC 1426	P Callan	Vol #:	22

EMC 1427	C Lizarraga	Vol #:	22

EMC 1428	D Gersetnfeld	Vol #:	22

EMC 1429	R Gersetnfeld	Vol #:	22

EMC 1430	K Stanley	Vol #:	22



EMC 1431	L Calisti	Vol #:	22

2004N-0230	Food; Current Good Manufacturing Practice Regulations; Public Meetings

C 12	H. Rubin	Vol #:	5

C 13	J. Meagher	Vol #:	5

C 14	A. Meade	Vol #:	5

C 15	S. Rapp	Vol #:	5

C 16	L. Hennessey, MD	Vol #:	5

C 17	Mrs Thompson	Vol #:	5

C 18	S. Bernal	Vol #:	5

C 19	I. Fitzgerald	Vol #:	5

C 20	S. Chhabra, PhD	Vol #:	5

C 21	M. Lassen	Vol #:	5

C 22	Allergy and Asthma Associates of Pittsburgh	Vol #:	5

C 23	J and J Holmstrom	Vol #:	5

C 24	R. Schoenauer	Vol #:	5

C 25	S , D and N Heise	Vol #:	5

C 26	K. Quinones	Vol #:	5

C 27	R. Voss	Vol #:	5

C 28	W. Voss	Vol #:	5

C 29	G. Spatacco	Vol #:	5

C 30	G. Spatacco	Vol #:	5

C 31	G. Spatacco	Vol #:	5

C 32	M. Hodgeman, Esq	Vol #:	5

C 33	M. Hodgeman, Esq	Vol #:	5

C 34	M. Hodgeman, Esq	Vol #:	5

C 35	M. Hodgeman, Esq	Vol #:	5

C 36	A. Lawson	Vol #:	5

C 37	E. Nourian	Vol #:	5

C 38	L. Blitzer	Vol #:	5

C 39	E. Pennington	Vol #:	5

C 40	M. Starr	Vol #:	5

C 41	L. Rich	Vol #:	5

C 42	L. Botwinick	Vol #:	5

C 43	N. Rosen	Vol #:	5

C 44	B Baker and Dr. R. Korenberg	Vol #:	5

C 45	S. Rosenzweig	Vol #:	5



C 46	Mr and Mrs T.W. Neville	Vol #:	5

C 47	Dr and Mrs D. Wysong	Vol #:	5

C 48	R and S Nash	Vol #:	5

C 49	Dr. M. Ziboh, MD	Vol #:	5

C 50	E. Wysong	Vol #:	5

C 51	T. Bragg	Vol #:	5

C 52	R. Martin	Vol #:	5

C 53	J. Aplin	Vol #:	5

C 54	S and J Larkin	Vol #:	5

C 55	T. Walker	Vol #:	5

C 56	J. Hendryx	Vol #:	5

C 57	P. Upton	Vol #:	5

C 58	G. Vaughan	Vol #:	5

C 59	G. Walker	Vol #:	5

C 60	M. Kaminski	Vol #:	5

C 61	E. Brown	Vol #:	5

C 62	H and S Brown	Vol #:	5

C 63	D. Barratt	Vol #:	5

C 64	D. Barratt	Vol #:	5

C 65	A. Docal	Vol #:	5

C 66	W. Boye	Vol #:	5

C 67	Arkansas Allergy & Asthma Clinic, PA	Vol #:	5

C 68	Arkansas Allergy & Asthma Clinic, PA	Vol #:	5

C 69	Mr and Mrs J and V Mangano	Vol #:	5

C 70	S and C Paulson	Vol #:	5

C 71	L. Weinhardt	Vol #:	5

C 72	S. DeLay	Vol #:	5

C 73	Arkansas Allergy & Asthma Clinic, PA	Vol #:	5

C 74	K. Kauke	Vol #:	5

C 75	R. Arndt	Vol #:	5

C 76	T. DeMann	Vol #:	5

C 77	A. Martinez	Vol #:	5

C 78	R. Gilbert	Vol #:	5

C 79	A. Aernouts	Vol #:	5

C 80	A. Bhai	Vol #:	5

C 81	L. Blumsack	Vol #:	5

C 82	L. Walsh	Vol #:	5



C 83	Mr and Mrs P and M Modica	Vol #:	5

C 84	Mr and Mrs C and T Coll	Vol #:	5

C 85	Mr and Mrs J and M Gilbride	Vol #:	5

C 86	B. Gorab	Vol #:	5

C 87	W. Bowman	Vol #:	5

C 88	A. Meyers	Vol #:	5

C 89	J. Meyers	Vol #:	5

C 90	P. Himeles	Vol #:	5

C 91	V. Welisch	Vol #:	5

C 92	R. Martikainen	Vol #:	5

C 93	R. Brown	Vol #:	5

C 94	Boos Family	Vol #:	5

C 95	L. Aronsky	Vol #:	5

C 96	A. Parker	Vol #:	5

C 97	R. Wallstrom, MD	Vol #:	5

C 98	D. Hoppe	Vol #:	5

C 99	M. Bosselman	Vol #:	5

C 100	R and K Chutter	Vol #:	5

C 101	K. Dix	Vol #:	6

C 102	N. Larenzo	Vol #:	6

C 103	D and S Faragher	Vol #:	6

C 104	B. Wallace	Vol #:	6

C 105	B and F Davis	Vol #:	6

C 106	J. Glasser, MD	Vol #:	6

C 107	D. Kent	Vol #:	6

C 108	P. Schwartz	Vol #:	6

C 109	P. Schwartz	Vol #:	6

C 110	H. Fenster	Vol #:	6

C 111	K. Walker, MD	Vol #:	6

C 112	M. Szmansky	Vol #:	6

C 113	Arkansas Allergy & asthma Clinic, PA	Vol #:	6

C 114	J. Goossen	Vol #:	6

C 115	E. Fogerty	Vol #:	6

C 116	M. Schaap	Vol #:	6

C 117	Dr and Mrs A Hucek	Vol #:	6

C 118	L and R Crocetti	Vol #:	6

C 119	K. Szafranski	Vol #:	6



C 120	C. Hall	Vol #:	6

C 121	S. Farris	Vol #:	6

C 122	D. Warick	Vol #:	6

C 123	L. Kozak	Vol #:	6

C 124	T. Waters	Vol #:	6

C 125	A. Furlong	Vol #:	6

C 126	B. Hella	Vol #:	6

C 127	B Foster	Vol #:	6

C 128	A and J Kosieradzki	Vol #:	6

C 129	P. Callaghan	Vol #:	6

C 130	N. Vaughan	Vol #:	6

C 131	J. Alt	Vol #:	6

C 132	C. Baiocco	Vol #:	6

C 133	J. Fabisiak	Vol #:	6

C 134	L. Slama	Vol #:	6

C 135	J. Miller	Vol #:	6

C 136	A. Hojnacke	Vol #:	6

C 137	H. Nowlin	Vol #:	6

C 138	University of Pittsburgh	Vol #:	6

C 139	C. Hunt	Vol #:	6

C 140	E. Bank	Vol #:	6

C 141	K. Voulalas,MS,RD,LD,CNSD	Vol #:	6

C 142	B. Kelly	Vol #:	6

C 143	J. Curran	Vol #:	6

C 144	E. Twombly	Vol #:	6

C 145	C. Starks	Vol #:	6

C 146	M. Bernal	Vol #:	6

C 147	H and T Schmitt	Vol #:	6

C 148	R. Hodgeman	Vol #:	6

C 149	R. Hodgeman	Vol #:	6

C 150	R. Hodgeman	Vol #:	6

C 151	E. Mills	Vol #:	6

C 152	N. Streiter	Vol #:	6

C 153	T. Hirsch	Vol #:	6

C 154	A. Porter	Vol #:	6

C 155	T. Kemper	Vol #:	6

C 156	E. Metayer	Vol #:	6



C 157	A. Tascone	Vol #:	6

C 158	H. Cochran	Vol #:	6

C 159	E. Recker	Vol #:	6

C 160	K. Perkins	Vol #:	6

C 161	M. Briggs	Vol #:	6

C 162	M and C Braun	Vol #:	6

C 163	D. Ryan	Vol #:	6

C 164	T. Thompson	Vol #:	6

C 165	G. Velsmid	Vol #:	6

C 166	R. Levin	Vol #:	6

C 167	R. Brandt	Vol #:	6

C 168	E. Barratt	Vol #:	6

C 169	S and P Nash	Vol #:	6

C 170	M. Thompson	Vol #:	6

C 171	K. Jones	Vol #:	6

C 172	M and D Lewis	Vol #:	6

C 173	D and S Behrendt	Vol #:	6

C 174	R. McDonald	Vol #:	6

C 175	E. DeSantis	Vol #:	6

C 176	C and M Fountain	Vol #:	6

C 177	A. Freeland	Vol #:	6

C 178	V. Lacher	Vol #:	6

C 179	J. Wiaz	Vol #:	6

C 180	H and P Armstrong	Vol #:	6

C 181	M and L Berg	Vol #:	6

C 182	J. Blaes	Vol #:	6

C 183	B. Spellacy	Vol #:	6

C 184	L and C Carson	Vol #:	6

C 185	D. Gerould	Vol #:	6

C 186	J and P Black	Vol #:	6

C 187	H and L Moses	Vol #:	6

C 188	J. Chomicki	Vol #:	6

C 189	K Hudspeth	Vol #:	6

C 190	D. Stiver	Vol #:	6

C 191	S. Markson	Vol #:	6

C 192	Ear, Nose & Throat Associates of Springfield, Inc.	Vol #:	6

C 193	Children's Hospital of Philadelphia	Vol #:	6



2004P-0379	Determine whether Penthrane inhalation has been voluntarily withdrawn from sale for safety or efficacy reasons

LET 1	HFD-005 to AAC Consulting Group	Vol #:	1

2005P-0096	ANDA 77-421 Loratadine Syrup- Hives relief

ACK 1	HFA-305 to Silarx Pharmaceuticals, Inc	Vol #:	1

CP 1	Silarx Pharmaceuticals, Inc	Vol #:	1

Page created on March 9, 2005 kk
Page updated on March 16, 2005 RC

FDA/Dockets Management