Food and Drug Administration
DOCKETS ENTERED on June 21, 1999 Table of Contents(Hyper links are at the end of the Docket title - click on * ) |
95S-0316 75-Day Premarket Notifications for New Dietary
Ingredients *
98N-0056 Sec 111(b)Pediatric Studies of list of Approved Drugs FDAMA * 98N-1038 Irradiation in the production, processing, &handling of food * 98P-0169 Labeling Standards for Botanicals, Homeopathics, etc. * 98P-1123 Suspend request to sponsors of pending & approved new animal * 99P-0340 Limited Exemption for Ephinephrine for Emergency Use * 99P-1172 Add alatrofloxacin to ped. priority list of approved drugs * 99P-1173 Add celebrex to pediatric priority list of approved drugs * 99P-1340 Declared Eternity eau de Parfum Misbranded * 99V-2014 Laser Light Shows * |
77N-0240 Single-Entity Coronary Vasodilators
SUP 26 KV Pharmaceutical Company Vol#: 48
SUP 27 Time-Cap Labs, Inc. Vol#: 52
95S-0316 75-Day Premarket Notifications for New Dietary Ingredients
RPT 44 Chick Cart Inc Vol#: 23
RPT 45 Cyanotech Corporation Vol#: 24
SUP 5 P&Y American Dietary Supplements Inc Vol#: 24
98D-0266 Section 121 Positron Emission Tomography (PET) FDAMA
REF 1 Briefing Book for June 28-29, 1999 MIDAC Vol#: 5
98H-1029 Civil Money Penalties;Metro Petroleum Inc.;d.b.a Terry Road
LET 2 Office of Policy Vol#: 1
SET 1 GCF-1 Vol#: 1
98H-1031 Civil Money Penalties;The Stop & Shop Companies Inc,d/b/a
LET 2 Office of Policy Vol#: 1
SET 1 GCF-1 Vol#: 1
98H-1032 Civil Money Penalties; Tobacco Superstores Inc,d/b/a #21
LET 2 Office of Policy Vol#: 1
SET 1 GCF-1 Vol#: 1
98H-1059 Civil Money Penalties;French Broad Trading Co Inc,d/b/a Fren
LET 2 Office of Policy Vol#: 1
SET 1 GCF-1 Vol#: 1
98H-1067 Civil Money Penalties;Fred's Store of Tennessee,d/b/a Fred's
LET 2 Office of Policy Vol#: 1
SET 1 GCF-1 Vol#: 1
98H-1068 Civil Money Penalties;Kroger Ltd Partnership I,d/b/a Krogers
LET 2 Office of Policy Vol#: 1
SET 1 GCF-1 Vol#: 1
98H-1069 Civil Money Penalties;McCardle Co Inc,d/b/a Hancock Convenie
LET 2 Office of Policy Vol#: 1
SET 1 GCF-1 Vol#: 1
98N-0056 Sec 111(b)Pediatric Studies of list of Approved Drugs FDAMA
LET 6 HFD-1 to Pfizer Inc. Vol#: 3
LET 7 HFD-1 to G. D. Searle & Company Vol#: 3
98N-1038 Irradiation in the production, processing, &handling of food
C 2955 Jennifer Caldwell Vol#: 80
C 2957 Robert G. Duerr Vol#: 80
C 2958 Timothy Johnston Vol#: 80
C 2959 James T. Morgan Vol#: 80
C 2962 Susan Sanders-Kinzel Vol#: 80
98P-0169 Labeling Standards for Botanicals, Homeopathics, etc.
C 3 Pharmacists Planning Service Vol#: 1
98P-1123 Suspend request to sponsors of pending & approved new animal
LET 1 HFV-2 to Animal Health Institute Vol#: 1
99H-0404 Civil Money Penalties;Mims Oil Co Inc,d/b/a Shellgo #524
ANS 1 Mims Enterprises dba Shellgo #524 Vol#: 1
99H-0497 Civil Money Penalties;Mims Oil Co Inc,d/b/a Jr Food Mart 611
ANS 1 Mims Enterprises dba Shellgo #611 Vol#: 1
99H-0498 Civil Money Penalties;Mims Oil Co Inc, d/b/a Shellgo #517
ANS 1 Mims Enterprises dba Shellgo #517 Vol#: 1
99H-0522 Civil Money Penalties;Mims Oil Co Inc,d/b/a Shellgo #20
ANS 1 Mims Enterprises dba Shellgo #20 Vol#: 1
99H-0660 Civil Money Penalty; Mims Oil Co Inc d/b/a Shell Go #519
ANS 1 Mims Enterprises dba Shellgo #519 Vol#: 1
99H-0694 Civil Money Penalty; Rite Aid Corp d/b/a Rite Aid #7216
LET 2 Office of Policy Vol#: 1
99H-0956 Civil Money Penalties;Lamountain Construction Inc,d/b/a Lamo
ANS 1 LaMountain's Snack Shop Vol#: 1
99H-1068 Civil Money Penalties;George S Smith & Dr Robert Smith,d/b/a
LET 2 Office of Tobacco Programs Vol#: 1
99H-1169 Civil Money Penalties;Restituto Catacutan & Juana Catacutan
ANS 1 Restituto A Catacutan Vol#: 1
99H-1182 Civil Money Penalties;Corborn's Inc,d/b/a Cash Wise
ANS 1 Coborn's Inc dba Cash Wise Store Vol#: 1
99H-1203 Civil Money Penalties; Manar Razooki & Mundhir Razooki,d/b/a
ANS 1 Kamil Mobil Mart Vol#: 1
99H-1237 Civil Money Penalties;Steve & Greta Hudson,d/b/a Steve's Cor
ANS 1 Stev'e Corner Vol#: 1
99H-1239 Civil Money Penalties;Pacific Foods Inc
ANS 1 Pacific Foods Vol#: 1
99H-1300 Civil Money Penalties;R O Lewis Inc & Ron O Lewis,d/b/a Jahn
ANS 1 R O Lewis Inc Vol#: 1
99H-1310 Civil Money Penalties;Young Do Koh & Yeo On Koh,d/b/a La Tie
ANS 1 Young Do Koh/Yeo On Koh Vol#: 1
99H-1313 Civil Money Penalties;Debbie Ogieglo & Myra Ogieglo,d/b/a
ANS 1 Jug "N" Plug Inc Vol#: 1
99H-1345 Civil Money Penalty; Luther Lee Barnes d/b/a Community Groce
ANS 1 Community Grocery Vol#: 1
99H-1354 Civil Money Penalty; Newcomb Oil Co & John L Newcomb Jr d/b/
ANS 1 Newcomb Oil Co Vol#: 1
99H-1379 Civil Money Penalty;James Pickle dba Mr. Pic
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1446 Civil Money Penalties;Edward Lorenz,d/b/a Super Stop
ANS 1 Super Stop Vol#: 1
99H-1452 Civil Money Penalties;Bill Nicol & Lina Nicol,d/b/a Nicol's
ANS 1 Nicol's Texaco Vol#: 1
99H-1490 Civil Money Penalties; Bobby Caulkins Inc,d/b/a Cauling Cono
ANS 1 Caulkins Conoco Vol#: 1
99H-1560 Civil Money Penalty;Paul Dever dba Dogwood General Store
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1712 Civil Money Penalties;Thomas Weinhandl,d/b/a Tom's Standard
ANS 1 Tom's Standard Vol#: 1
99H-1770 Civil Money Penalty;Rapid Roberts Inc dba Rapid Roberts
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1771 Civil Money Penalty;B & K Foods Inc dba Country Mart
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#:
99H-1772 Civil Money Penalty;American Eagle Mgmt Inc dba GA Traveler
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1773 Civil Money Penalty;Pine Island Farmers Elevator Co dba Pine
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1774 Civil Money Penalty;Hancock Coutry Cooperative Oil Assn dba
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1775 Civil Money Penalty;J H Harvey Co dba Harvey's Supermarkets
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1776 Civil Money Penalty;J H Harvey Co dba Harvey's Supermarket #
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1777 Civil Money Penalty;Kato Inc dba Pump 'n Munch
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1778 Civil Money Penalty;Kato Inc dba Pump 'n Munch
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1779 Civil Money Penalty;The Pantry Inc dba The Pantry #921
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1780 Civil Money Penalty;The Pantry Inc dba The Pantry #933
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1781 Civil Money Penalty;Hannaford Brothers Co dba Hannaford Supe
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1782 Civil Money Penalty;Express Food Mart Inc dba Express Food M
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1783 Civil Money Penalty;Irving Oil Corp dba New Hampton Irving
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1784 Civil Money Penalty;Amvets Home Inc dba Amvet Post 19
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1785 Civil Money Penalty;Mobil Oil Corp dba Mobil Oil
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1786 Civil Money Penalty;Chevron Stations Inc dba Winchester Payn
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1787 Civil Money Penalty;Hossain Erfan Khaziri d/b/a Hamilton Unn
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1788 Civil Money Penalty;Manjit Dhillon d/b/a Creedmoor Food Stor
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1789 Civil Money Penalty;Ronald Bair d/b/a Daly Oil Company
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1790 Civil Money Penalty;Linda Downer d/b/a Linda's One Stop
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1791 Civil Money Penalty;Jimmy Black Jr. d/b/a Jimmy's Corner Sto
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1792 Civil Money Penalty;William C. Jennings & Sandra Jennings db
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1793 Civil Money Penalty;Kuen Ng Wong & Jose Loo d/b/a Peso Compa
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1794 Civil Money Penalty;Ven L. Lee & Jennie Lee d/b/a A & P Liqu
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99P-0340 Limited Exemption for Ephinephrine for Emergency Use
PDN 1 HFD-1 to Edward B Frankel MD Vol#: 1
99P-1172 Add alatrofloxacin to ped. priority list of approved drugs
PAV 1 HFD-1 to Pfizer, Inc. Vol#: 1
99P-1173 Add celebrex to pediatric priority list of approved drugs
PAV 1 HFD-1 to G. D. Searle & Company Vol#: 1
99P-1340 Declared Eternity eau de Parfum Misbranded
C 109 Judith Constable Vol#: 3