Dockets Entered on May 7, 2004

Dockets Management



Dockets Entered On May 7, 2004 Table of Contents



Docket #	Title

1995S-0117	Human Drugs Patent Term Extension & New Patents

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

2000N-1571	Enrofloxacin for Poultry: Opportunity for Hearing

2000P-1211	Establish Mandatory Pre-Market Safety Testing for GE Foods

2003D-0206	Draft Guidance for Industry on Exocrine Pancreatic Insufficiency Drug Products; Availability

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

2003N-0205	Exocrine Pancreatic Insufficiency Drug Products

2003N-0565	Agency Information Collection Activities; Proposed Collection; Comment Request; Generic FDA Rapid Response Surveys

2004D-0146	Guidance for Industry: Validation of Analytical Procedures for Type C Medicated Feeds

2004D-0187	Guidance for Industry on Premarketing Risk Assessment

2004D-0188	Guidance for Industry on Development and Use of Risk Minimization Action Plans

2004D-0189	Guidance for Industry on Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment

2004N-0159	Schering Corp. et al.; Withdrawal of Approval of 92 New Drug Applications and 49 Abbreviated New Drug Applications

2004N-0184	Requirements Pertaining to Sampling and Private Laboratories Used in Connection With Importing Food

2004P-0219	ANDA Suitability for Doxycycline Monohydrate Capsules, 150mg

2004P-0220	determine that the reference listed drug Zithromax (azithromycin) oral capsules,NDAS 50-670 was not withdrawn from sale for reasons related to safety or effectiveness

2004V-0218	Laser Light Show

1995S-0117	Human Drugs Patent Term Extension & New Patents

LST 92	List as of March 5, 2004	Vol #:	7

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

LET 13891	Enzymatic Therapy	Vol #:	118

LET 13892	Enzymatic Therapy	Vol #:	118

LET 13893	Enzymatic Therapy	Vol #:	118

LET 13894	Enzymatic Therapy	Vol #:	118

LET 13895	Enzymatic Therapy	Vol #:	118

LET 13896	Enzymatic Therapy	Vol #:	118

LET 13897	Enzymatic Therapy	Vol #:	118

LET 13898	Enzymatic Therapy	Vol #:	118

LET 13899	Enzymatic Therapy	Vol #:	118

LET 13900	Enzymatic Therapy	Vol #:	118

LET 13901	Enzymatic Therapy	Vol #:	118

LET 13902	Enzymatic Therapy	Vol #:	118

LET 13903	Enzymatic Therapy	Vol #:	118

LET 13904	Enzymatic Therapy	Vol #:	118

LET 13905	Enzymatic Therapy	Vol #:	118



LET 13906	Enzymatic Therapy	Vol #:	118

LET 13907	Enzymatic Therapy	Vol #:	119

LET 13908	Enzymatic Therapy	Vol #:	119

LET 13909	Enzymatic Therapy	Vol #:	119

LET 13910	Enzymatic Therapy	Vol #:	119

LET 13911	Enzymatic Therapy	Vol #:	119

LET 13912	Enzymatic Therapy	Vol #:	119

LET 13913	Enzymatic Therapy	Vol #:	119

LET 13914	Enzymatic Therapy	Vol #:	119

LET 13915	Enzymatic Therapy	Vol #:	119

LET 13916	Enzymatic Therapy	Vol #:	119

LET 13917	Enzymatic Therapy	Vol #:	119

LET 13918	Enzymatic Therapy	Vol #:	119

LET 13919	Enzymatic Therapy	Vol #:	119

2000N-1571	Enrofloxacin for Poultry: Opportunity for Hearing

EMC 747	Lisa Wood	Vol #:	271

EXB 32	CVM	Vol #:	403

EXB 33	CVM	Vol #:	403

2000P-1211	Establish Mandatory Pre-Market Safety Testing for GE Foods

EMC 5835	Maria Chambers	Vol #:	789

EMC 5836	Maria Chambers	Vol #:	789

EMC 5837	Carlos Guillermo	Vol #:	789

2003D-0206	Draft Guidance for Industry on Exocrine Pancreatic Insufficiency Drug Products; Availability

GDL 1	Guideline	Vol #:	1

NAD 1	FDA	Vol #:	1

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

LST 1	Korangy Radiology Associates, P.A., et al	Vol #:	2

LST 2	GCF-1	Vol #:	2

2003N-0205	Exocrine Pancreatic Insufficiency Drug Products

BKG 1	Background Information Refs 1 - 18	Vol #:	1

N 1	FDA	Vol #:	1

2003N-0565	Agency Information Collection Activities; Proposed Collection; Comment Request; Generic FDA Rapid Response Surveys

N 2	FDA	Vol #:	1



2004D-0146	Guidance for Industry: Validation of Analytical Procedures for Type C Medicated Feeds

GDL 1	Guideline	Vol #:	1

NAD 1	FDA	Vol #:	1

2004D-0187	Guidance for Industry on Premarketing Risk Assessment

GDL 1	Guideline	Vol #:	1

NAD 1	FDA	Vol #:	1

2004D-0188	Guidance for Industry on Development and Use of Risk Minimization Action Plans

GDL 1	Guideline	Vol #:	1

NAD 1	FDA	Vol #:	1

2004D-0189	Guidance for Industry on Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment

GDL 1	Guideline	Vol #:	1

NAD 1	FDA	Vol #:	1

2004N-0159	Schering Corp. et al.; Withdrawal of Approval of 92 New Drug Applications and 49 Abbreviated New Drug Applications

NWL 1	FDA	Vol #:	1

2004N-0184	Requirements Pertaining to Sampling and Private Laboratories Used in Connection With Importing Food

BKG 1	Background Material Refs 1 - 16	Vol #:	1

NPR 1	FDA	Vol #:	1

2004P-0219	ANDA Suitability for Doxycycline Monohydrate Capsules, 150mg

ACK 1	HFA-305 to Lachman Consultant Services, Inc.	Vol #:	1

CP 1 Attachment 1, 2, 3	Lachman Consultant Services, Inc.	Vol #:	1

2004P-0220	determine that the reference listed drug Zithromax (azithromycin) oral capsules,NDAS 50-670 was not withdrawn from sale for reasons related to safety or effectiveness

ACK 1	Wapner,Newman,Wigrizer,Brecher	Vol #:	1

CP 1	Wapner,Newman,Wigrizer,Brecher	Vol #:	1

2004V-0218	Laser Light Show

ACK 1	HFA-305 to Dreamlight Laser Productions	Vol #:	1

VAR 1	Dreamlight Laser Productions	Vol #:	1

Page created on May 10, 2004 kk

FDA/Dockets Management