| | | | | | | | | | |
| |
|
|
| Dockets Entered
On Januray 5, 2005
Table of Contents
|
|
|
|
|
|
|
| |
|
|
| Docket #
|
| Title
|
|
|
|
|
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
| |
|
|
| 1997S-0163
|
| Dietary Supplements, Courtesy Letters (Letters of Objection)
|
| |
|
|
| 1998P-0151
|
| Introduction Of Downed Cattle Into The Food Supply
|
| |
|
|
| 1999P-1231
|
| Revise Labeling on Tamoxifen (Nolvadex)
|
| |
|
|
| 1999P-5106
|
| Identify Sources of Natural Flavorings
|
| |
|
|
| 2000N-0504
|
| Egg Safety Action Plan
|
| |
|
|
| 2000N-1571
|
| Enrofloxacin for Poultry: Opportunity for Hearing
|
| |
|
|
| 2005P-0006
|
| ANDA Suitability Petition for Bumetanide Injection, USP 10mg/40 mL
|
| |
|
|
| 2005P-0007
|
| ANDA Suitability for Risperidone Orally Disintegrating Tablets, 0.25 mg
|
| |
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
| |
|
|
| LET
15169
|
| NBTY Inc.
|
| Vol #:
|
| 134
|
| |
|
|
| LET
15170
|
| NBTY Inc.
|
| Vol #:
|
| 134
|
| |
|
|
| LET
15171
|
| NBTY Inc.
|
| Vol #:
|
| 134
|
| |
|
|
| LET
15172
|
| NBTY Inc.
|
| Vol #:
|
| 134
|
| |
|
|
| LET
15173
|
| NBTY Inc.
|
| Vol #:
|
| 134
|
| |
|
|
| LET
15174
|
| NBTY Inc.
|
| Vol #:
|
| 134
|
| |
|
|
| LET
15175
|
| NBTY Inc.
|
| Vol #:
|
| 134
|
| |
|
|
| LET
15176
|
| NBTY Inc.
|
| Vol #:
|
| 134
|
| |
|
|
| LET
15177
|
| NBTY Inc.
|
| Vol #:
|
| 134
|
| |
|
|
| LET
15178
|
| NBTY Inc.
|
| Vol #:
|
| 134
|
| |
|
|
| LET
15179
|
| NBTY Inc.
|
| Vol #:
|
| 134
|
| |
|
|
| LET
15180
|
| NBTY Inc.
|
| Vol #:
|
| 134
|
| |
|
|
| LET
15181
|
| NBTY Inc.
|
| Vol #:
|
| 134
|
| |
|
|
| LET
15182
|
| NBTY Inc.
|
| Vol #:
|
| 134
|
| |
|
|
| LET
15183
|
| NBTY Inc.
|
| Vol #:
|
| 134
|
| |
|
|
| LET
15184
|
| NBTY Inc.
|
| Vol #:
|
| 134
|
| |
|
|
| LET
15185
|
| NBTY Inc.
|
| Vol #:
|
| 134
|
| |
|
|
| LET
15186
|
| NBTY Inc.
|
| Vol #:
|
| 134
|
| |
|
|
| LET
15187
|
| NBTY Inc.
|
| Vol #:
|
| 134
|
| |
|
|
| LET
15188
|
| NBTY Inc.
|
| Vol #:
|
| 134
|
| |
|
|
| LET
15189
|
| NBTY Inc.
|
| Vol #:
|
| 134
|
| |
|
|
| LET
15190
|
| AdvoCare International, L.P.
|
| Vol #:
|
| 134
|
| |
|
|
| LET
15191
|
| AdvoCare International, L.P.
|
| Vol #:
|
| 134
|
| |
|
|
| LET
15192
|
| AdvoCare International, L.P.
|
| Vol #:
|
| 134
|
| |
|
|
| LET
15193
|
| AdvoCare International, L.P.
|
| Vol #:
|
| 134
|
|
| | | | | | | | |
| |
|
|
| LET
15194
|
| AdvaCare International, L.P.
|
| Vol #:
|
| 134
|
| |
|
|
| LET
15195
|
| Kemin Consumer Care, L.C.
|
| Vol #:
|
| 134
|
| |
|
|
| LET
15196
|
| Leiner Health Products
|
| Vol #:
|
| 134
|
| |
|
|
| LET
15197
|
| NBTY Inc.
|
| Vol #:
|
| 134
|
| |
|
|
| LET
15198
|
| NBTY Inc.
|
| Vol #:
|
| 134
|
| |
|
|
| LET
15199
|
| NBTY Inc.
|
| Vol #:
|
| 134
|
| |
|
|
| LET
15200
|
| NBTY Inc.
|
| Vol #:
|
| 134
|
| |
|
|
| LET
15201
|
| NBTY Inc.
|
| Vol #:
|
| 134
|
| |
|
|
| LET
15202
|
| NBTY Inc.
|
| Vol #:
|
| 134
|
| |
|
|
| LET
15203
|
| NBTY Inc.
|
| Vol #:
|
| 134
|
| |
|
|
| 1997S-0163
|
| Dietary Supplements, Courtesy Letters (Letters of Objection)
|
| |
|
|
| LET
796
|
| HFS-800 to ImmunAct, Inc
|
| Vol #:
|
| 24
|
| |
|
|
| LET
797
|
| HFS-800 to Source Naturals
|
| Vol #:
|
| 24
|
| |
|
|
| LET
798
|
| HFS-800 to 21st Century Nutritional Products Inc
|
| Vol #:
|
| 24
|
| |
|
|
| LET
799
|
| HFS-800 to NOW Foods
|
| Vol #:
|
| 24
|
| |
|
|
| LET
800
|
| HFS-800 to Market America Inc
|
| Vol #:
|
| 24
|
| |
|
|
| LET
801
|
| HFS-800 to Enzymatic Therapy
|
| Vol #:
|
| 24
|
| |
|
|
| LET
802
|
| HFS-800 to NOW Foods
|
| Vol #:
|
| 24
|
| |
|
|
| 1998P-0151
|
| Introduction Of Downed Cattle Into The Food Supply
|
| |
|
|
| C 7466
|
| A. Felix
|
| Vol #:
|
| 319
|
| |
|
|
| 1999P-1231
|
| Revise Labeling on Tamoxifen (Nolvadex)
|
| |
|
|
| PAV
1
|
| HFD-001 to Public Citizen Health Research Group
|
| Vol #:
|
| 1
|
| |
|
|
| 1999P-5106
|
| Identify Sources of Natural Flavorings
|
| |
|
|
| C 70
|
| Mr and Mrs E. Searcy
|
| Vol #:
|
| 3
|
| |
|
|
| 2000N-0504
|
| Egg Safety Action Plan
|
| |
|
|
| C 286
|
| K. Wright
|
| Vol #:
|
| 26
|
| |
|
|
| C 287
|
| G. Vorderstrasse
|
| Vol #:
|
| 26
|
| |
|
|
| C 288
|
| G. Finnegan
|
| Vol #:
|
| 26
|
| |
|
|
| C 289
|
| V. Crompton
|
| Vol #:
|
| 26
|
| |
|
|
| C 290
|
| G. Seventson
|
| Vol #:
|
| 26
|
| |
|
|
| C 291
|
| E. Anderson
|
| Vol #:
|
| 26
|
| |
|
|
| C 292
|
| K. Tirigotis
|
| Vol #:
|
| 26
|
| |
|
|
| C 293
|
| Illegible
|
| Vol #:
|
| 26
|
| |
|
|
| C
294
|
| United Egg
|
| Vol #:
|
| 26
|
|
| | | | | | | | |
| |
|
|
| C 295
|
| B. Lamoreaux
|
| Vol #:
|
| 26
|
| |
|
|
| C 296
|
| J. Gemaghty
|
| Vol #:
|
| 26
|
| |
|
|
| C 297
|
| M. Prendergast
|
| Vol #:
|
| 26
|
| |
|
|
| C 298
|
| J. Espoz
|
| Vol #:
|
| 26
|
| |
|
|
| C 299
|
| T. Mason
|
| Vol #:
|
| 26
|
| |
|
|
| C
300
|
| Clancy Associates
|
| Vol #:
|
| 26
|
| |
|
|
| C 301
|
| D. Thater
|
| Vol #:
|
| 26
|
| |
|
|
| C
302
|
| Sparboe Summitt Farms, LLC
|
| Vol #:
|
| 26
|
| |
|
|
| C 303
|
| K. Lopez
|
| Vol #:
|
| 26
|
| |
|
|
| 2000N-1571
|
| Enrofloxacin for Poultry: Opportunity for Hearing
|
| |
|
|
| EXB 803
|
| Bayer Corporation
|
| Vol #:
|
| 470
|
| |
|
|
| EXB 804
|
| Bayer Corporation
|
| Vol #:
|
| 470
|
| |
|
|
| EXB 805
|
| Bayer Corporation
|
| Vol #:
|
| 470
|
| |
|
|
| EXB 806
|
| Bayer Corporation
|
| Vol #:
|
| 470
|
| |
|
|
| EXB 807
|
| Bayer Corporation
|
| Vol #:
|
| 470
|
| |
|
|
| EXB 808
|
| Bayer Corporation
|
| Vol #:
|
| 470
|
| |
|
|
| EXB 809
|
| Bayer Corporation
|
| Vol #:
|
| 470
|
| |
|
|
| EXB 810
|
| Bayer Corporation
|
| Vol #:
|
| 470
|
| |
|
|
| EXB 811
|
| Bayer Corporation
|
| Vol #:
|
| 470
|
| |
|
|
| EXB 812
|
| Bayer Corporation
|
| Vol #:
|
| 470
|
| |
|
|
| EXB 813
|
| Bayer Corporation
|
| Vol #:
|
| 470
|
| |
|
|
| EXB 814
|
| Bayer Corporation
|
| Vol #:
|
| 470
|
| |
|
|
| EXB 815
|
| Bayer Corporation
|
| Vol #:
|
| 470
|
| |
|
|
| EXB 816
|
| Bayer Corporation
|
| Vol #:
|
| 470
|
| |
|
|
| EXB 817
|
| Bayer Corporation
|
| Vol #:
|
| 470
|
| |
|
|
| EXB 818
|
| Bayer Corporation
|
| Vol #:
|
| 470
|
| |
|
|
| EXB 819
|
| Bayer Corporation
|
| Vol #:
|
| 470
|
| |
|
|
| EXB 820
|
| Bayer Corporation
|
| Vol #:
|
| 470
|
| |
|
|
| EXB 821
|
| Bayer Corporation
|
| Vol #:
|
| 470
|
| |
|
|
| 2005P-0006
|
| ANDA Suitability Petition for Bumetanide Injection, USP 10mg/40 mL
|
| |
|
|
| ACK
1
|
| HFA-305 to Ben Venue Laboratories
|
| Vol #:
|
| 1
|
| |
|
|
| CP
1
Attachment
1, 2
|
| Ben Venue Laboratories
|
| Vol #:
|
| 1
|
| |
|
|
| 2005P-0007
|
| ANDA Suitability for Risperidone Orally Disintegrating Tablets, 0.25 mg
|
| |
|
|
| ACK
1
|
| HFA-305 to Lachman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| CP
1
Attachment
1, 2,
3
|
| Lachman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
|
|
