Dockets Entered on August 20, 2007



Dockets Entered On August 20, 2007



Docket #	Title

1978N-0038	Sunscreen Drug Products

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

2006N-0454	Use of Ozone-Depleting Substances; Removal of Essential-Use Designations

2006P-0394	Revise the labeling requirements for eggs sold in the United States

2007P-0326	To determine whether Sanorex (Mazindol) Tablets, 1 and 2 mg, (NDA 17-247), by Novartis, have been voluntarily withdrawn or withheld from sale for safety or efficacy reasons.

1978N-0038	Sunscreen Drug Products

BKG 4	FDA/HFD-560	Vol #:	154

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

LET 20574	Source Naturals	Vol #:	180

LET 20575	Ferrosan, Inc.	Vol #:	180

LET 20576	Highland Laboratories	Vol #:	180

LET 20577	Source Naturals	Vol #:	180

LET 20578	Bayer HealthCare	Vol #:	180

LET 20579	Enzmatic	Vol #:	180

LET 20580	Enzmatic	Vol #:	180

LET 20581	Enzmatic	Vol #:	180

LET 20582	Enzmatic	Vol #:	180

LET 20583	Enzmatic	Vol #:	180

LET 20584	Enzmatic	Vol #:	180

LET 20585	Enzmatic	Vol #:	180

LET 20586	Enzmatic	Vol #:	180

LET 20587	Enzmatic	Vol #:	180

LET 20588	INTEGRITY	Vol #:	180

LET 20589	INTEGRITY	Vol #:	180

LET 20590	NBTY	Vol #:	180

LET 20591	NBTY	Vol #:	180

LET 20592	NBTY	Vol #:	180

LET 20593	NBTY	Vol #:	180

LET 20594	NBTY	Vol #:	180

LET 20595	NBTY	Vol #:	180

LET 20596	NBTY	Vol #:	180

LET 20597	Enzmatic	Vol #:	180

LET 20598	Natural Factors nutritional Products Inc.	Vol #:	180

LET 20599	KONSYL	Vol #:	180

LET 20600	NUTRAMAX LABORATORIES, INC.	Vol #:	180



LET 20601	NUTRAMAX LABORATORIES, INC.	Vol #:	180

LET 20602	Enzmatic	Vol #:	180

LET 20603	CAU ZONE	Vol #:	180

LET 20604	Planetary Herbals	Vol #:	180

LET 20605	Hillestad	Vol #:	180

LET 20606	Hillestad	Vol #:	180

LET 20607	ABKIT, INC.	Vol #:	180

LET 20608	ABKIT, INC.	Vol #:	180

LET 20609	ABKIT, INC.	Vol #:	180

LET 20610	ABKIT, INC.	Vol #:	180

LET 20611	ABKIT, INC.	Vol #:	180

LET 20612	NBTY	Vol #:	180

LET 20613	Hillestad	Vol #:	180

LET 20614	Hillestad	Vol #:	180

LET 20615	NUTRAMAX LABORATORIES, INC.	Vol #:	180

2006N-0454	Use of Ozone-Depleting Substances; Removal of Essential-Use Designations

C 1036	L. Callahan	Vol #:	11

C 1037	D. Young	Vol #:	11

C 1038	J. GoForth	Vol #:	11

C 1039	F. Dean	Vol #:	11

C 1040	S. Bussard	Vol #:	11

C 1041	M. Ciriaco	Vol #:	11

C 1042	A. Goldstein	Vol #:	11

C 1043	M. McGovern	Vol #:	11

C 1044	M. Jennings	Vol #:	11

C 1045	S. Smith	Vol #:	11

C 1046	B. Ramga	Vol #:	11

C 1047	K. Hicks	Vol #:	11

C 1048	R. Dolan	Vol #:	11

C 1049	E. Patton	Vol #:	11

C 1050	R. Vanderslice	Vol #:	11

C 1051	O. Murdock	Vol #:	11

C 1052	M. Snyder	Vol #:	11

C 1053	D. Sobczak	Vol #:	11

C 1054	R. Hook	Vol #:	11

C 1055	M. Hofmann	Vol #:	11



C 1241	K Richardson	Vol #:	12

C 1242	S Markussen	Vol #:	12

C 1243	S. Phillips	Vol #:	12

C 1244	R. Marbry	Vol #:	12

C 1245	M Sweeney	Vol #:	12

2006P-0394	Revise the labeling requirements for eggs sold in the United States

C 130	Demi Karpouzos	Vol #:	7

C 131	Amy E. Bissell	Vol #:	7

C 132	Denise Frozier	Vol #:	7

C 133	Bill Dieffenbach	Vol #:	7

C 134	Ronald McDavid	Vol #:	7

C 135	Nettie Schwager	Vol #:	7

2007P-0326	To determine whether Sanorex (Mazindol) Tablets, 1 and 2 mg, (NDA 17-247), by Novartis, have been voluntarily withdrawn or withheld from sale for safety or efficacy reasons.

ACK 1	FDA /DDM / To AAI Pharma, Inc.	Vol #:	1

CP 1	AAI Pharma, Inc.	Vol #:	1

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FDA/Dockets Management