Food and Drug Administration, Dockets Management Branch, 5630 Fishers Lane - Room 1061- HFA-305, Rockville, MD, 20852; 301-827-6860; Fax 301-827-6870  [E-mail]  

DOCKETS ENTERED on November 1, 1999

Table of Contents

(Hyper links are part of the Docket  title - not all dockets/documents are linked)

[FDA DOCKETS PAGE][FDA HOME PAGE]

 
91N-0103 Fatty Acids & Heart Disease, Hlth.Claims & Label Statements *
96P-0023 Amend 101.12(b) Table 2 on Hard Candies *
96P-0179 Establishes RACCs for various types of food products candies *
97D-0433 In Vivo Bioequivalence Studies Based on Population *
98D-0969 Effects of antimicrobial new animal drugs/use in food-produc *
98N-0313 Surgeons's and Patient Examination Gloves Reclassification *
98N-0581 Requirements for Testing Human Blood Donors *
98P-0145 Requirements for demonstrating In Vivo Bioequivalence *
98P-0434 Standards for Generic Transdermal Estradiol Patches *
99D-1149 In Vivo Pharmacokinetics & Bioavail Levothyroxine Sodium Tab *
99P-1653 ANDA for Pamidronate Disodium Injection *
99P-2247 Propoxyphene Napsylate/Acetaminophen 100mg/325mg *
99P-2252 Pamidronate Disodium Injection 3 mg/ml,6 mg/ml,9 mg/ml *
99P-2630 Establish a Daily Value for "added sugars" *

91N-0103 Fatty Acids & Heart Disease, Hlth.Claims & Label Statements

EXT 4 Consumer Healthcare Products Association Vol#: 29
 
 

96P-0023 Amend 101.12(b) Table 2 on Hard Candies

LET 2 HFS-151 King & Spaulding Vol#: 3
 
 

96P-0179 Establishes RACCs for various types of food products candies

LET 2 HFS-151 King & Spaulding Vol#: 3
 
 

97D-0433 In Vivo Bioequivalence Studies Based on Population

C 24 Global Regulatory Intelligence Vol#: 2
 
 

98D-0969 Effects of antimicrobial new animal drugs/use in food-produc

C 5 American Assn of Swine Practitioners Vol#: 2

98D-1146 Microbial effects of antimicrobial new animal drugs/human sa

C 64 Sharon Chen Vol#: 2

98H-1051 Civil Money Penalties;Thomas H. Healy Inc,d/b/a The Golden

CS 1 HFA-305 Vol#: 1

CS 2 HFA-305 Vol#: 1
 
 

98N-0313 Surgeons's and Patient Examination Gloves Reclassification

EXT 2 HIMA Vol#: 5

98N-0562 Civil Money Penalties; Rajaram K Matkari

CS 3 HFA-305 Vol#: 2

OR 3 HF-3 Vol#: 2
 
 

98N-0581 Requirements for Testing Human Blood Donors

C 5 Penn State Geisinger Health System Vol#: 5
 
 

98P-0145 Requirements for demonstrating In Vivo Bioequivalence

PDN 1 HFD-1 to Andrx Pharmaceutical Inc. Vol#: 5
 
 

98P-0434 Standards for Generic Transdermal Estradiol Patches

C 10 Hon James Ramstad (CI) Vol#: 2
 
 

99D-1149 In Vivo Pharmacokinetics & Bioavail Levothyroxine Sodium Tab

C 3 Knoll Pharmaceutical Company Vol#: 1

99F-4372 National Fisheries Institute and the Louisiana Dep of Agricu

N 1 National Fisheries Institute Vol#: 1

99H-4363 Civil Money Penalty;Preston Aust,dba Rock C Store

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4364 Civil Money Penalty;Fred Coscia,dba Fred's Cigar Store

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4365 Civil Money Penalty;June Ent Inc,dba Carrollton Exxon

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4366 Civil Money Penalty;John Micalizzi,dba Washington St Getty

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4367 Civil Money Penalty;O T Ent LLC,dba Old Town Market & Deli

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4368 Civil Money Penalty;Rebel Oil Co Inc,dba Union 76 Gas

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4369 Civil Money Penalty;Terry Neal Setzer,dba The Super

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4370 Civil Money Penalty;Super Discount Gas Inc,dba Super Discoun

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4377 Civil Money Penalty;Bouquet Inc,dba Mobil

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4378 Civil Money Penalty;Robert Brown Inc,dba Brown's Phillips 66

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4379 Civil Money Penalty;Conrad Foods Inc,dba Conrad Foods

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4380 Civil Money Penalty;CVS Revco D S Inc,dba CVS #5355

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4381 Civil Money Penalty;Davis Oil Co Inc,dba Circle D Mart

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4382 Civil Money Penalty;Huddleston Oil Co,dba American Self Serv

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4383 Civil Money Penalty;Robert Hudson,dba Food King-Searcy #2608

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4384 Civil Money Penalty;Bradly Alan Joslin Inc,dba The Tobacco

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4385 Civil Money Penalty;King of Clubs Inc,dba King of Clubs

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4386 Civil Money Penalty;Randy Meints & Richard Groninga,dba The

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4387 Civil Money Penalty;Mini Mart Inc,dba Loaf 'N Jug #15

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4388 Civil Money Penalty;Michael L Neal,dba Neals Grocery & Marke

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4389 Civil Money Penalty;Jesse Norman & Betty A Norman,dba Norman

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4390 Civil Money Penalty;QCS Inc,dba Fastway Food Mart

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4391 Civil Money Penalty;Russell Ramage,dba Westfield Store

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4392 Civil Money Penalty;Rebel Oil Co Inc,dba 76 Gas

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4393 Civil Money Penalty;R J M Inc,dba Byers Market

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4394 Civil Money Penalty;Ms Joan Rodie,dba Lone Tree Inn

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99N-1174 Development of Strategy for Dietary Supplements

C 60 Metabolife International Inc Vol#: 6
 
 

99P-1653 ANDA for Pamidronate Disodium Injection

LET 1 HFD-600 to Mitchell G Clark Vol#: 1
 
 

99P-2247 Propoxyphene Napsylate/Acetaminophen 100mg/325mg

SUP 1 Mikart, Inc. Pharmaceutical Manufacturer Vol#: 1
 
 

99P-2252 Pamidronate Disodium Injection 3 mg/ml,6 mg/ml,9 mg/ml

LET 1 HFD-600 to Faulding Pharmaceutical Co. Vol#: 1
 
 

99P-2630 Establish a Daily Value for "added sugars"

SUP 1 CSPI Vol#: 3