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Dockets Management
Dockets Entered On March 23, 2006
Table of Contents
Docket # Title
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
2001P-0230 Domestic Marketing & Importation of Transgenic Fish
2003P-0544 Modify existing food additive regulation with respect to the irradiation of ground beef byproducts
2004P-0223 Whole Grain Descriptive Claims
2004P-0359 Suitability Petition for (New Strength) Methacholine Chloride 1280 mg/vial
2004P-0511 ANDA for Methacholine Chloride 1280 mg/vial
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
2005P-0436 ADA 21-863' Ibuprogen Liquid filled gelatin capsules 200 mg; Ranbaxy Laboratories, Ltd.
2006P-0089 Stay approval of all supplements to biologics licenses issued to Genentech ( BLA# 103705 ) and Biogen ( BLA# 103737) for Rituxan ( Rituximab)
2006P-0123 Request that all applicants for fentanyl transdermal systems conduct a study to support the safety of their fentanyl transdermal products
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
LET 17373 Perrigo Company of South Carolina Vol #: 159
LET 17374 Perrigo Company of South Carolina Vol #: 159
LET 17375 Perrigo Company of South Carolina Vol #: 159
LET 17376 Perrigo Company of South Carolina Vol #: 159
LET 17377 Perrigo Company of South Carolina Vol #: 159
LET 17378 Perrigo Company of South Carolina Vol #: 159
LET 17379 Perrigo Company oF South Carolina Vol #: 159
LET 17380 Perrigo Company of South Carolina Vol #: 159
LET 17381 Perrigo Company of South Carolina Vol #: 159
LET 17382 Perrigo Company of South Carolina Vol #: 159
LET 17383 Perrigo Company of South Carolina Vol #: 159
LET 17384 Somalabs, Inc. Vol #: 159
LET 17385 Somalabs, Inc. Vol #: 159
LET 17386 Somalabs, Inc. Vol #: 159
LET 17387 Somalabs, Inc. Vol #: 159
LET 17388 Somalabs, Inc. Vol #: 159
LET 17389 Somalabs, Inc. Vol #: 159
LET 17390 Somalabs, Inc. Vol #: 159
LET 17391 Somalabs, Inc. Vol #: 159
LET 17392 Cosmetic Act, XanGo, LLC Vol #: 159
LET 17393 Cell Tech International Incorporated Vol #: 159
LET 17394 Natrol, Inc. Vol #: 159
LET 17395 InVite Health Vol #: 159
2001P-0230 Domestic Marketing & Importation of Transgenic Fish
C 1374 C Baird Vol #: 259
2003P-0544 Modify existing food additive regulation with respect to the irradiation of ground beef byproducts
C 53 C Baird Vol #: 5
2004P-0223 Whole Grain Descriptive Claims
C 30 Alton Spiller Inc Vol #: 5
2004P-0359 Suitability Petition for (New Strength) Methacholine Chloride 1280 mg/vial
WDL 1 Methapharm Vol #: 1
2004P-0511 ANDA for Methacholine Chloride 1280 mg/vial
WDL 1 ACIC Vol #: 1
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
C 3887 K S Oglesby Vol #: 66
C 3888 K M Ferra Vol #: 66
C 3889 P Conway Vol #: 66
C 3890 C Stewart Vol #: 66
C 3891 L Blengins Vol #: 66
C 3892 G Brader Vol #: 66
C 3893 S Leachman Vol #: 66
C 3894 D E. Stephens Vol #: 66
C 3895 J McDevitt Vol #: 66
C 3896 S Lemery Vol #: 66
C 3897 J Sacvitz Vol #: 66
C 3898 E R Spencer Vol #: 66
C 3899 N Green Vol #: 66
C 3900 L Pond Vol #: 66
C 3901 J Croke MD Vol #: 66
C 3902 D Harbin Vol #: 66
C 3903 Dr. C Kemmer Vol #: 66
C 3904 Dr. C Kemmer Vol #: 66
C 3905 E Pililsky Vol #: 66
C 3906 N Ganetano Vol #: 66
C 3907 J L Wikinson Vol #: 66
C 3908 B N Albritten Vol #: 66
C 3909 K Black Vol #: 66
C 3910 J Darrow Vol #: 66
C 3911 S Andwitz Vol #: 66
C 3912 C Blanchard Vol #: 66
C 3913 S Cavaros Vol #: 66
C 3914 L Conner Vol #: 66
C 3915 D James Vol #: 66
C 3916 R Grass Vol #: 66
C 3917 M Woods Vol #: 66
C 3918 D M Vogelheim Vol #: 66
C 3919 J Upmans Vol #: 66
C 3920 R Wolf Vol #: 66
C 3921 B A Fisk Vol #: 66
C 3922 S Upham Vol #: 66
C 3923 L M Cossa Vol #: 66
C 3924 C Prelle Vol #: 66
C 3925 N Ogden Vol #: 66
C 3926 P M Krenzer Vol #: 66
C 3927 P Herington Vol #: 66
C 3928 S W Collison Vol #: 66
C 3929 L Glover Vol #: 66
C 3930 F Cooley Vol #: 66
C 3931 D P Kleinschuster Vol #: 66
C 3932 P Tyrol Vol #: 66
C 3933 M Pourshahidi Vol #: 66
C 3934 D Yateman Vol #: 66
C 3935 M PIckenheim Vol #: 66
C 3936 V Norris Vol #: 66
C 3937 R Franks Vol #: 66
C 3938 T Anagnost Vol #: 66
C 3939 C Grobman Vol #: 66
C 3940 C Riddle Vol #: 66
C 3941 C Worman Vol #: 66
C 3942 B Kanefsky Vol #: 66
C 3943 I Dolena Vol #: 66
C 3944 S Uhl Vol #: 66
C 3945 B Nichols Vol #: 66
C 3946 C Sadler Vol #: 66
C 3947 D Altree Vol #: 66
C 3948 P Brazelton Vol #: 66
C 3949 G M Glynn Vol #: 66
C 3950 M Stoffregen Vol #: 66
C 3951 M Foreman Vol #: 66
C 3952 D Robinson Vol #: 66
C 3953 P Polland Vol #: 66
C 3954 J Johnston RN BSN PHN Vol #: 66
C 3955 L Snead Vol #: 66
C 3956 L Snead Vol #: 66
C 3957 S Hoover Vol #: 66
C 3958 S Hartry Vol #: 66
C 3959 K Steinberger Vol #: 66
EC 19585 Mrs. Gladys Tucker Vol #: 72
EC 19586 Ms. Judith Poe Vol #: 72
EC 19587 Miss. Mary Ann Rounseville Vol #: 72
EC 19588 Ms. Wendy Bros Vol #: 72
EC 19589 Mr. Walter B. Norris Vol #: 72
EC 19590 Jeffrey Dach MD,PA Vol #: 72
EC 19591 Ms. Leisa Meyers Vol #: 72
EC 19592 Mrs. Pamela Duke Vol #: 72
EC 19593 Mr. Keith Baldwin Vol #: 72
EC 19594 na Vol #: 72
EC 19595 Ms. DEBRA ADAMS Vol #: 72
EC 19596 Mrs. Tiffany Robertson Vol #: 72
EC 19597 Mrs. Margaret Brown Vol #: 72
EC 19598 Mrs. Sandra Probst Vol #: 72
EC 19599 Ms. Linda Lombardo Vol #: 72
EC 19600 Mrs. Virginia Reed Vol #: 72
EC 19601 Mr. Steven Hollabaugh Vol #: 72
EC 19602 Mr. Joseph Guilfoyle Vol #: 72
EC 19603 Mrs. Christine Guilfoyle Vol #: 72
EC 19604 FOYE HIGHLANDS Vol #: 72
EC 19605 Ms. Margaret Adie Vol #: 72
EC 19606 Mrs. Timothea Petze Vol #: 72
EC 19607 Mrs. Donna Stroud Vol #: 72
EC 19608 Mrs. Susan Russell Vol #: 72
EC 19609 Mrs. Greta Mendes Vol #: 72
EC 19610 Ms. D Reichel Vol #: 72
EC 19611 Mrs. tammy collinsworth Vol #: 72
EC 19612 Miss. Chelsea Kingston Vol #: 72
EC 19613 Ms. Judy Cross Vol #: 72
EC 19614 Mrs. Victoria Hodge Vol #: 72
EC 19615 Mr. Ernest Hotze Vol #: 72
EC 19616 Mr. Andrew Arken Vol #: 72
EC 19617 Mrs. Brenda Wightman Vol #: 72
EC 19618 Mrs. Carrie Nelson Vol #: 72
EC 19619 Mrs. Nadine Ellis Vol #: 72
EC 19620 Mrs. Georgia Simpson Vol #: 72
EC 19621 Mr. Charles Frangos Vol #: 72
EC 19622 Ms. Kathryn Marley Vol #: 72
EC 19623 Mr. jerry roma Vol #: 72
EC 19624 Ms. V Jackson Vol #: 72
EC 19625 Mrs. Theodora Hale Vol #: 72
EC 19626 Ms. Theodora Calafates Vol #: 72
EC 19627 Miss. Ruth DePalma Vol #: 72
EC 19628 Ms. Shakti Khalsa Vol #: 72
EC 19629 Mrs. Cheryl Rausch Vol #: 72
EC 19630 Ms. Sheila Plaskon Vol #: 72
EC 19631 Mrs. Rita Childers Vol #: 72
EC 19632 Mr. Justo Augusto Vol #: 72
EC 19633 Mrs. Brenda Benda Vol #: 72
EC 19634 Mrs. Mindy Kelly Vol #: 72
EC 19635 Ms. Janie Hadley Vol #: 72
EC 19636 Mrs. Twila Lopez Vol #: 72
EC 19637 Ms. Marcia Rhode Vol #: 72
EC 19638 Mrs. Taletha Barr Vol #: 72
EC 19639 Mrs. Darci Epperson Vol #: 72
EC 19640 Mrs. Rebecca Hadley Vol #: 72
EC 19641 none-individual Vol #: 72
EC 19642 Ms. Susan Clark Vol #: 72
EC 19643 Ms. Joan Prefontaine Vol #: 72
EC 19644 Mrs. Gloria Askew Vol #: 72
EC 19645 Ms. Lee Ann Ferris Vol #: 72
EC 19646 Mrs. Bett Juroff Vol #: 72
EC 19647 Mr. Bill Eason Vol #: 72
EC 19648 Ms. Pamela Inman Vol #: 72
EC 19649 Mrs. Linda Cronquist Vol #: 72
EC 19650 Mrs. Janice Halstead Vol #: 72
EC 19651 Mrs. Debra Young Vol #: 72
EC 19652 Mr. gary milo Vol #: 72
EC 19653 Health central women's care Vol #: 72
EC 19654 Mrs. Lisa Scruggs Vol #: 72
EC 19655 Mrs. SARAH Smith Vol #: 72
EC 19656 Ms. Leah Seals Vol #: 72
EC 19657 Cassona Vol #: 72
EC 19658 Mrs. Jean Keith Vol #: 72
EC 19659 Mrs. frances farkas Vol #: 72
EC 19660 Ms. T L Dow Vol #: 72
EC 19661 Mr. Gary Preston Vol #: 72
EC 19662 N/A Vol #: 72
EC 19663 Ms. April Tarras Vol #: 72
EC 19664 Mr. Maxwell Parrish Vol #: 72
EC 19665 Ms. mary kavathas Vol #: 72
EC 19666 Dr. Anna Lombroso Vol #: 72
EC 19667 Ms. Candace Cook Vol #: 72
2005P-0436 ADA 21-863' Ibuprogen Liquid filled gelatin capsules 200 mg; Ranbaxy Laboratories, Ltd.
SUP 2 Banner Pharmacaps Inc. Vol #: 1
2006P-0089 Stay approval of all supplements to biologics licenses issued to Genentech ( BLA# 103705 ) and Biogen ( BLA# 103737) for Rituxan ( Rituximab)
LET 1 Genentech Inc Vol #: 1
2006P-0123 Request that all applicants for fentanyl transdermal systems conduct a study to support the safety of their fentanyl transdermal products
SUP 1 Mylan Laboratories Inc. Vol #: 1

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