Dockets Entered on November 29, 2005

Dockets Management



Dockets Entered On November 29, 2005 Table of Contents



Docket #	Title

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

2002N-0273	Animal Proteins Prohibited in Ruminant Feed

2003P-0531	Issue a report providing the necessary information on pill weight tolerances and/or variations caused by reformulations

2004D-0453	Compliance Policy Guide Sec. 560.400 - 'Imported Milk and Cream Federal Import Milk Act (CPG 7119.05)'

2005D-0312	Guidance for Industry on ANDAs: Impurities in Drug Products; Chemistry, Manufacturing, and Controls Information; Availability

2005D-0385	Guidance for Industry on Using Electronic Means to Distribute Certain Product Information

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

2005N-0311	Critical Path Initiative; Developing Prevention Therapies; Planning of Workshop

2005P-0116	To take the following actions with regard to aqueous-based drugs for inhalation that has been compounded by pharmacy operations

2005P-0221	amend the regulations governing the labeling of milk products in Part 131 of the Title 21 of the Code of Federal Regulations

2005P-0436	ADA 21-863' Ibuprogen Liquid filled gelatin capsules 200 mg; Ranbaxy Laboratories, Ltd.

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

LET 16977	NDS Nutritiion, LLC	Vol #:	153

LET 16978	NDS Nutrition, LLC	Vol #:	153

LET 16979	NDS Nutrition, LLC	Vol #:	153

LET 16980	NDS Nutrition, LLC	Vol #:	153

LET 16981	NDS Nutrition, LLC	Vol #:	153

LET 16982	NDS Nutrtion, LLC	Vol #:	153

LET 16983	NDS Nutrition, LLC	Vol #:	153

LET 16984	Enzymatic Therapy	Vol #:	153

LET 16985	NDS Nutrition, LLC	Vol #:	153

LET 16986	The Procter and Gamble Company	Vol #:	153

LET 16987	Mindkeepers, Inc.	Vol #:	153

LET 16988	Hillestad Pharmaceutical	Vol #:	153

LET 16989	Hillestad Pharmaceutical	Vol #:	153

LET 16990	New Chapter, Inc.	Vol #:	153

LET 16991	New Chapter, Inc.	Vol #:	153

LET 16992	Pharmavite LLC	Vol #:	153

LET 16993	DMD Pharmaceuticals	Vol #:	153

LET 16994	DMD Pharmaceuticals	Vol #:	153

LET 16995	Millennium Biotechnologies, Inc.	Vol #:	153

LET 16996	Enzymatic Therapy	Vol #:	153

2002N-0273	Animal Proteins Prohibited in Ruminant Feed

C 220	W. Bagley	Vol #:	24

C 221	H. Bietry	Vol #:	24



C 222	Eligible	Vol #:	24

C 223	M. Londo	Vol #:	24

C 224	S. Ng	Vol #:	24

C 225	S. Hoyt	Vol #:	24

C 226	Eligible	Vol #:	24

C 227	J. Fuentes	Vol #:	24

C 228	W. Cruz	Vol #:	24

C 229	J. Ramirez	Vol #:	24

C 230	Eligible	Vol #:	24

C 231	R. Soria	Vol #:	24

C 232	Eligible	Vol #:	24

C 233	Eligible	Vol #:	24

C 234	Eligible	Vol #:	24

C 235	Eligible	Vol #:	24

C 236	M. Lewis	Vol #:	24

C 237	Eligible	Vol #:	24

C 238	Eligible	Vol #:	24

C 239	Eligible	Vol #:	24

C 240	M. Renesa	Vol #:	24

C 241	A. Cordova	Vol #:	24

C 242	N. Nagel	Vol #:	24

C 243	C. Beiler	Vol #:	24

C 244	R. Martin	Vol #:	24

C 245	F. Martin	Vol #:	24

C 246	Valley Proteins, Inc.	Vol #:	24

C 247	C. Esh	Vol #:	24

C 248	D. Stotgfer	Vol #:	24

C 249	M. McElwain	Vol #:	24

C 250	N. Muller	Vol #:	24

C 251	T. Embry	Vol #:	27

C 252	M. Bulleri	Vol #:	27

C 253	K. Zeigler	Vol #:	27

C 254	T. Enriquez	Vol #:	24

C 255	T. Thompson	Vol #:	27

C 256	M. Dillon	Vol #:	27

C 257	D. Sarber	Vol #:	27

C 258	J. Carr	Vol #:	27



2003P-0531	Issue a report providing the necessary information on pill weight tolerances and/or variations caused by reformulations

LET 3	Fulcrum Inc.	Vol #:	1

LET 4	HFD-240 to Fulcrum Inc.	Vol #:	1

2004D-0453	Compliance Policy Guide Sec. 560.400 - 'Imported Milk and Cream Federal Import Milk Act (CPG 7119.05)'

C 8	J. Lamp	Vol #:	1

C 9	R and K Breneman	Vol #:	1

2005D-0312	Guidance for Industry on ANDAs: Impurities in Drug Products; Chemistry, Manufacturing, and Controls Information; Availability

C 3	Sandoz GmbH	Vol #:	1

2005D-0385	Guidance for Industry on Using Electronic Means to Distribute Certain Product Information

C 1	Abbott	Vol #:	1

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

MO 4	GCF-1, TMJ Implants, Inc. and Robert W. Christensen and Maureen K . Mooney	Vol #:	1

RMO 1	TMJ Implants, Inc, and Robert W. Christensen, and Maureen K Mooney	Vol #:	1

2005N-0311	Critical Path Initiative; Developing Prevention Therapies; Planning of Workshop

C 4	Novartis Pharmaceuticals Corporation (Novartis)	Vol #:	1

2005P-0116	To take the following actions with regard to aqueous-based drugs for inhalation that has been compounded by pharmacy operations

C 9	T. Kralj	Vol #:	2

2005P-0221	amend the regulations governing the labeling of milk products in Part 131 of the Title 21 of the Code of Federal Regulations

LET 1	HFS-800 to City of Allentown Health Bureau	Vol #:	1

2005P-0436	ADA 21-863' Ibuprogen Liquid filled gelatin capsules 200 mg; Ranbaxy Laboratories, Ltd.

AMD 1	Banner Pharmacaps Inc.	Vol #:	1

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FDA/Dockets Management