Regulatory Information
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2000 Chronological List of Petitions and Advisory Opinions
To view actual documents, make a note of the docket number, go to regulations.gov and enter the docket number in the search box. You will then get everything associated with that docket number.
Interim Response is not a final decision on the petition.
January | February | March | April | May | June | July | August | September | October | November | December
| Date Filed | Docket # | Name of Petitioner/Subject Matter | Disposition |
|---|---|---|---|
| January | |||
| 01/04/2000 | 2000P-0090 | Pentech Pharmaceuticals Inc/Determine Paxil Oral Capsules not withdrawn for safety reaso | |
| 01/04/2000 | 2000P-0091 | Mitchall G Clark/ANDA Suitability for Pamidronate Disodium Injection | |
| 01/05/2000 | 2000P-0092 | GensiaSicor Pharmaceuticals/ANDA Suitability for Thiotepa for Injection | |
| 01/05/2000 | 1999P-5589 | Ethicon, Inc./Reclassification of Absorbable Polydioxanone Surgical Suture | |
| 01/05/2000 | 1999V-5588 | Gulf World, Inc./Laser Light Show | |
| 01/07/2000 | 2000P-0110 | Merck & Co. Inc./Add finasteride to priority section of "the List" | |
| 01/07/2000 | 2000V-0111 | Active Production & Design/Laser Light Show (Mobolazer ML10-200,ML-300,ML10-300W, | |
| 01/07/2000 | 2000V-0112 | Creative Artists Productions/Laser Light SHow | |
| 01/10/2000 | 2000P-0117 | Phoenix Scientific Inc/ANADA Suitability for Lincomycin-Spectinomycin Water Soluble | |
| 01/10/2000 | 2000V-0135 | Peppermill Casino/Variance Laserium CSLP Projector | |
| 01/11/2000 | 2000P-0177 | Robert Cohen/Request that FDA not Approve Upjohn's Bovine Growth Hormone | |
| 01/14/2000 | 2000H-0211 | Candyman Productions/Laser Light Show | |
| 01/18/2000 | 2000P-0219 | Andrx Pharmaceuticals Inc./Verapamil Hydrochloride Extended-Release Tablets | |
| 01/27/2000 | 2000V-0310 | Museum of Science and History/Laser Light Show | |
| 01/27/2000 | 2000V-0354 | Chabot Observatory & Science Center/Laser Light Show,Omniscan Laser Projection System,2000 Serie |
|
| 01/28/2000 | 2000P-0442 | Ludlow Technical Products/Variance from Perf Std for Electrode Lead Wires & Patient Ca | |
| 01/31/2000 | 2000A-0355 | Marcode/Industrial Marking Equipment Regarding Food Packing | |
| 01/31/2000 | 2000V-0353 | The Shops at Sunset Place/Laser Light Show | |
| Top | |||
| February | |||
| 02/01/2000 | 2000P-0443 | Pace Medical Inc/Exempt Model 4220 Sterile Disposable Surgical Extension Cabe | |
| 02/03/2000 | 2000P-0425 | Mead Johnson/To amend 21 CFR 107 Subpart B,labeling of infant formulas | |
| 02/03/2000 | 1999P-1589 | Roxane Laboratories, Inc/Stay effective date of approval for NDA 20-932 Roxicodone | |
| 02/04/2000 | 2000P-0444 | Phoenix Scientific Inc/ANADA Suitability for spectinomycin sterile solution | |
| 02/04/2000 | 1998N-0044 | Nutraceutical Corporation/Effect of dietary supplement on structure/function of body | |
| 02/04/2000 | 2000P-0499 | Apotex Inc/Review/Act on SKB '132 Form C & '423 Form A patent for NDA20 | |
| 02/07/2000 | 2000N-0506 | Grocery Manufacturers of America/Safety Issues Associated With Dietary Supplements | |
| 02/07/2000 | 2000P-0497 | Baxter Healthcare Corporation/Exemption for the Baxter Volumetric Catheters | |
| 02/07/2000 | 2000P-0498 | Baxter Healthcare Corporation/Exempt Swan-Ganz Pacing Catheters and Probes | |
| 02/07/2000 | 2000V-0496 | Advanced Lighting & Production Services/Laser Light Show | |
| 02/07/2000 | 1998N-0044 | Grocery Manufacturers of America/Effect of dietary supplement on structure/function of body | |
| 02/07/2000 | 1998N-0044 | American Herbal Products Association/Effect of dietary supplement on structure/function of body | |
| 02/07/2000 | 1998N-0044 | CRN & CHPA/Effect of dietary supplement on structure/function of body | |
| 02/07/2000 | 1998N-0044 | CRN & CHPA/Effect of dietary supplement on structure/function of body | |
| 02/07/2000 | 1998N-0044 | McNeil Consumer Healthcare/Effect of dietary supplement on structure/function of body | |
| 02/10/2000 | 2000V-0570 | Pulse Laser Productions,LLC/Laser Light Show | |
| 02/10/2000 | 2000V-0576 | Event FX/Laser Light Show Mobolazer ML10-250,ML10-300,ML10-300W,ML100 | |
| 02/11/2000 | 2000P-0585 | Lachman Consultant Services, Inc./Prozac (Fluoxetine) Tablets Voluntarily Withdrawn | |
| 02/11/2000 | 2000P-0586 | Natl Cheese Inst,Grocery Mfg of America/Amend Pt 133.3 re:Milk and Nonfat Milk for use in Standardiz | |
| 02/12/2000 | 2000P-0653 | The James Madison Project/Amend the product insert &/or label for Anthrax Vaccive adso | |
| 02/14/2000 | 2000V-0654 | Daddy Rocks, Inc/Mobolazer ML10-200, ML10-300, ML10-300W, ML10-1000, ML10-2.5 | |
| 02/14/2000 | 2000P-0596 | Phoenix Scientific, Inc,/ANADA consisting of different physical form of drug product | |
| 02/15/2000 | 2000V-0610 | Insight Technology Incorporated/Infrared Laser Aiming Light | |
| 02/15/2000 | 2000V-0611 | Insight Technology Incorporated/( Visible and IR Laser Aiming Module (LAM) | |
| 02/15/2000 | 2000V-0612 | Insight Technology Incorporated/Laser Aiming Device (AN/PAQ-4C) | |
| 02/18/2000 | 2000P-0685 | National Yogurt Association/Revise of Yogurt Standards | |
| 02/22/2000 | 2000V-0724 | Mac Shane Laser Art Productions/Laser Light Show, Laser Art Series | |
| 02/24/2000 | 2000P-0787 | Abbott Laboratories/Electrode Lead Wires/Patient Cables of 21 CFR part 898 | |
| 02/25/2000 | 2000V-0791 | Preston Productions Inc./Laser Light Show | |
| 02/28/2000 | 2000P-0804 | Thomas G. Crouthamel, Sr./FD&C Yellow #5 & FD&C Blue #1 Labeling | |
| 02/29/2000 | 2000P-0788 | Advanced Neuromodulation Systems, Inc./Totally Implanted Spinal Cord Stimulator | |
| 02/29/2000 | 2000V-0808 | Extreme Dome Enterainment/Laser Light Show Entreme Dome- Centrar Starbeam CKO3 | |
| Top | |||
| March | |||
| 03/01/2000 | 2000P-0842 | Thomas Blake, R.Ph./Zantac 75 Effervescent Tablets | |
| 03/01/2000 | 2000V-0877 | Science Museum of Minnesota/Laser Light Show | |
| 03/01/2000 | 2000V-0878 | Franklin Institute Science Museum/Laser Light Show | |
| 03/02/2000 | 2000V-0893 | The Lions Share Inc/Laser Light Show | |
| 03/03/2000 | 2000P-0913 | McDermott, Will & Emery/ANDA suitability for Albuterol Sulfate inhalation solution, | |
| 03/07/2000 | 2000V-0980 | Carnegie Science Center/Laser light show (Omniscan laser projection system) | |
| 03/07/2000 | 2000V-1058 | Tom Casey/Laser Light Show | |
| 03/08/2000 | 2000P-0931 | Perkin Elmer Wallac Inc./Wallac's Neonatal Biotinidase Kit, Models NB-1000, NB-4000 | |
| 03/09/2000 | 2000V-1035 | Donald Pascual/Laser Light Show Mobolazer ML10-200,ML10-300,ML10-3000W | |
| 03/10/2000 | 2000V-1059 | Rick's Durty Harrys Entertainment Comple/Laser light show | |
| 03/13/2000 | 2000P-1077 | The Humane Society of the United States/Amend Current Reg Banning Sale of Small Turtles | |
| 03/13/2000 | 2000P-1084 | Public Citizen's Health Group/Diabetes Drugs Troglitazone,rosiglitazone,pioglitazone | |
| 03/13/2000 | 2000P-1117 | Med Mira Laboratories Inc./Reclassify QuickAir Choke Reliever, Model 59-001A | |
| 03/13/2000 | 2000V-1076 | GDM Event Services/Laser Light Show Mobolazer ML10-200,ML10-300,ML10-300W,ML100 | Approved 06/01/2006 |
| 03/13/2000 | 2000P-1085 | American Orthotic & Prosthetic Ass/Classify cranial helment in class I,exempt from premarket | |
| 03/14/2000 | 2000P-1120 | UroSurge/UroSurge Percutaneous SANS Device | |
| 03/14/2000 | 2000V-1118 | Millenium Dance Club/Laser Light Show(Mobolazer ML10-200,ML10-300,ML10-300W,) | |
| 03/15/2000 | 2000V-1125 | New Pacific Inc./Laser Light Show (Mobolazer ML10-200,ML10-300,ML10-300W, | |
| 03/15/2000 | 2000V-1126 | SSI Production Services, Inc./Laser Light Show(Mobolazer ML10-200,ML10-300,ML10-300W, | |
| 03/15/2000 | 2000V-1127 | South Florida Science Museum/Laser Light Show | Approved 11/03/2006 |
| 03/16/2000 | 2000P-1199 | Biovail Corporation/Approval of ANDAs for Extended-Release | |
| 03/16/2000 | 2000V-1158 | System Concepts/Laser Light Show(Mobolazer ML10-200,ML10-300,ML10-300W, | |
| 03/17/2000 | 1978N-0036L | C.B. Fleet Company, Inc./OTC Laxative | |
| 03/22/2000 | 2000P-1210 | Occupational Knowledge International/Restrict Sale of Coal Tar-Containing Products | |
| 03/22/2000 | 2000P-1211 | Center for Food Safety/Establish Mandatory Pre-Market Safety Testing for GE Foods | |
| 03/23/2000 | 2000V-1222 | The Amphitheater/Laser light show | |
| 03/23/2000 | 2000P-1213 | Ferring Pharmaceuticals/ANDA injectable formulation calcitonin salmon (caltine) | |
| 03/24/2000 | 1988N-0258 | U.S. Small Business Administration/Prescription Drug Marketing Act of 1987; Guideline | |
| 03/24/2000 | 1992N-0297 | U.S. Small Business Administration/Prescription Drug Marketing Act of 1987, Drug Amds of 1992 | |
| 03/29/2000 | 2000V-1221 | Long Island Laser Work/Laser Light Show (Long Island Laser Work) | Approved 05/06/2005 |
| 03/31/2000 | 2000P-1209 | KaVo America Corporation/Laser Flurescence Caries Detection Device | |
| 03/31/2000 | 2000P-1225 | Equi Aid Products, Inc./ANADA Suitability for Ivermectin Liquid for Horses | |
| 03/31/2000 | 1988N-0258 | Pharmaceutical Distributors Association/Prescription Drug Marketing Act of 1987; Guideline | |
| 03/31/2000 | 1992N-0297 | Pharmaceutical Distributors Association/Prescription Drug Marketing Act of 1987, Drug Amds of 1992 | |
| Top | |||
| April | |||
| 04/03/2000 | 2000P-1227 | Center for Science in the Public Interes/Amend Statements Made for Dietary Supplements | |
| 04/06/2000 | 1975N-0183H | HFD-001 to Intnat'l Lab Technology Corp/Health-Care Antiseptic Drug Products for OTC Human Use | |
| 04/07/2000 | 2000P-1240 | CPR Medical Products Inc/Variance from Perf Std for Electrode Lead Wires & Patient Ca | |
| 04/07/2000 | 2000P-1243 | Pharmaceutical Associates Inc./ANDA Suitability for Hydrocodone Bitartrate/Acetaminophen | |
| 04/07/2000 | 2000V-1232 | Ballinger Music/Laser Light Show | |
| 04/07/2000 | 2000V-1241 | Maryland Science Center/Laser Light Show | |
| 04/07/2000 | 2000V-1244 | Light Source/Laser Light Show | |
| 04/11/2000 | 2000P-1245 | Lachman Consultant Services, inc./ANDA for Nizatidine Capsules, 75mg | |
| 04/11/2000 | 2000V-1247 | Lazer Wizardry/Laser Light Show | Approved 10/02/2003; Approved 10/02/2003;Terminated 06/01/2005; Approved 07/20/2005; Approved 12/15/2006; Approved 06/05/2007 |
| 04/13/2000 | 2000P-1258 | GE Marquette Medical Systems Inc et al/Standard for Electrode Lead Wires and Patient Cables | |
| 04/14/2000 | 2000V-1259 | See Factory/Laser Light Show | |
| 04/14/2000 | 2000V-1260 | American Music Co./Laser light show | |
| 04/18/2000 | 2000V-1261 | FluoroScan Imaging Systems, Inc./FluoroScan Premier mini C-Arm | |
| 04/18/2000 | 1992N-0412 | Raj Matkari/Debarment of Raj Matkari; Notice of Opportunity for Hearing | |
| 04/19/2000 | 2000P-1263 | Genelabs Technologies, Inc/Initiation of Procedure to Determine Whether DHEA is exclude | |
| 04/20/2000 | 2000V-1264 | GE Medical Systems OEC/Source-skin distance requirement of the performance standard | |
| 04/21/2000 | 2000P-1265 | Biosense Webster Inc/Performance standard for electrode lead wires & patient cabl | |
| 04/25/2000 | 2000P-1270 | King & Spalding/ANDA for combination oxycodone hydrochloride/acetaminophen | |
| 04/26/2000 | 2000V-1272 | Aggessive Sound Inc./Laser Light Show | |
| 04/26/2000 | 1983P-0187 | Associated Pharmacologists & Toxicologis/Refrain from Approval of Polyurethane Contraceptive Sponge |
|
| 04/27/2000 | 2000N-0598 | Grocery Manufacturers of America (GMA)/Dietary Supplement Health Claim/Implementation of Pearson De |
|
| 04/27/2000 | 2000P-1271 | King & Spalding/Oxycodone hydrochloirde/acetaminophen tablet 2.5mg/400mg;5.0 | |
| 04/27/2000 | 2000V-1273 | Broadway Magic/Laser Light Show | |
| Top | |||
| May | |||
| 05/02/2000 | 2000P-1279 | Chattanooga Group Inc/Extend the Compliance Dates for Electrode Lead Wires and Pat | |
| 05/02/2000 | 2000P-1280 | Abbott Laboratories/Exempt Devices Classified as Total Triiodothyronine Test Sys | |
| 05/02/2000 | 2000V-1281 | La Curacao/Laser Light Show, LM 8 Projection System | APPROVED 09/16/2003 Approved 9/16/2003;Terminated 8/17/2005 |
| 05/03/2000 | 2000V-1285 | Mid South Laser Shows/Laser light show | |
| 05/04/2000 | 2000A-1288 | Daniel Kearns/Bioburden, Environmental Monitoring | |
| 05/05/2000 | 2000P-1282 | UrosMetrics/EROS-Clitoral Therapy Device | |
| 05/05/2000 | 2000P-1284 | Grocery Mfrs of America et al/General info for making claims ref about lack of use of food | |
| 05/05/2000 | 2000P-1286 | EP MedSystems, Inc./Performance standard for electrode lead wires & patient cabl | |
| 05/08/2000 | 2000V-1287 | Main Light Industries, Inc/Laser Light Show | APPROVED 05/14/2004 |
| 05/08/2000 | 1999P-4613 | Robert Cohen/Revoke the Regulation That Approved Posilac | |
| 05/09/2000 | 2000P-1289 | GensiaSicor Pharmaceuticals/Submission of supplement to abbreviated new drug application | |
| 05/09/2000 | 2000P-1290 | Prizm Medical, Inc./Performance standard for electrode lead wire & patient cable | |
| 05/09/2000 | 2000P-1291 | Pharmaceutical Assoc Inc/Opioid anagesic elixir drug product suitable under an ANDA | |
| 05/10/2000 | 2000P-1292 | Amrex-Zetron Inc/Performance Standard for Electrode Lead Wires & Patient Cabl | |
| 05/11/2000 | 2000P-1275 | Lipton/Health Claim: Vegetable oil sterol esters & coronary heart d | |
| 05/11/2000 | 1998N-0044 | Consumer Healthcare Products Assn/Effect of dietary supplement on structure/function of body | |
| 05/12/2000 | 2000P-1295 | Accelerated Care Plus/Performance Standard for Electrode Lead Wires & Patient Cabl | |
| 05/12/2000 | 2000V-1293 | Vision Digital Media/Laser light show | |
| 05/12/2000 | 2000V-1294 | J.A. Investments, Inc dba Lava Lanes of/Laser Light Show | |
| 05/17/2000 | 2000P-1297 | Arnall Golden & Gregory, LLP/Permit an OTC drug mfg to include "may contain" in label | |
| 05/18/2000 | 2000V-1301 | G World Productions/Laser Light Show | |
| 05/18/2000 | 2000V-1302 | Carnegie Science Center/Laser Light Show | |
| 05/19/2000 | 2000P-1304 | Boston Scientific EP Technologies/Variance from application of the performance standard | |
| 05/22/2000 | 2000P-1308 | Lachman Consultant Services, Inc./Methimazole tablets USP,15mg/20mg are suitable for ANDA | |
| 05/22/2000 | 2000V-1310 | Pegasus Productions/Laser Light Show Projector | |
| 05/24/2000 | 2000P-1276 | McNeil Consumer Healthcare/Health Claim: Plant stanol esters and heart disease | |
| 05/24/2000 | 2000V-1312 | Cox Chiropractic Associates, Inc./Variance to Performance Standard for Electrical Lead Wires | |
| 05/25/2000 | 2000P-1297 | Arnall Golden & Gregory, LLP/Permit an OTC drug mfg to include "may contain" in label | |
| 05/30/2000 | 2000P-1322 | State of New York,MD,MI,WY,OH,TN,CT,VT,M/Food Labeling and Allergen Contamination Control | |
| 05/30/2000 | 2000P-1324 | Mikart, Inc/Propoxyphene Napsylate/Acetaminophen 100 Mg/500mg | |
| 05/30/2000 | 2000P-1330 | University of Pennsylvania/Regulation approving the dosage approved for drug Propecia | |
| 05/30/2000 | 2000V-1323 | Allen Memorial Planetarium/Laser Light Show | |
| 05/31/2000 | 2000P-1319 | IOMED, Inc./Performance Standard for Electrode Lead Wires & Patient Cabl | |
| 05/31/2000 | 2000P-1320 | Allegiance Healthcare Corporation/Performance Standard for Electrode Lead Wires & Patient Cabl | |
| 05/31/2000 | 2000P-1325 | Aspirin Foundation of America Inc/Declare Tylenol Arthritis Extended Relief Misbranded | |
| Top | |||
| June | |||
| 06/01/2000 | 2000N-0598 | Durk Pearson and Sandy Shaw et al./Dietary Supplement Health Claim/Implementation of Pearson De | |
| 06/01/2000 | 2000P-1326 | American Seafood Distritutors Assoc/Crabmeat; Amendment of Common or Usual Name Regulation | |
| 06/01/2000 | 2000P-1342 | Phoenix Scientific, Inc./Minor change in a generic Pyrantel Pamoate Paste | |
| 06/01/2000 | 2000V-1327 | Adlaser Pty Ltd/Medi-laze Smart Laser Product | |
| 06/05/2000 | 2000P-1329 | Arnall Golden & Gregory, LLP./Permit dietary supplement manufacturer to include the phrase | |
| 06/06/2000 | 2000V-1331 | Silver Hammer of Nevada LLC./Laser Light Show | |
| 06/07/2000 | 2000V-1337 | Miner Mike's Inc./Laser Light Show | |
| 06/08/2000 | 2000V-1333 | Falls Park Sound and Light Show Inc./Laser Pro Projector | |
| 06/08/2000 | 2000V-1334 | J.A. Investments, Inc./Laser Light Show | |
| 06/12/2000 | 2000V-1338 | Instant Request Inc/Laser Light Show | |
| 06/13/2000 | 2000P-0586 | NCI, NAPA & GMA/Amend Pt 133.3 re:Milk and Nonfat Milk for use in Standardiz | |
| 06/13/2000 | 2000P-1340 | Able Laboratories, Inc./Withdrawn of ROWASA Suppositories | |
| 06/13/2000 | 2000V-1339 | Club Fusion/Laser Display Device | |
| 06/15/2000 | 2000P-1343 | E-Z-EM, Inc./Reclassify Barium Enema Retention Catheter to Class II | |
| 06/19/2000 | 2000P-1349 | St. Jude Medical/Variance for Electrode Lead Wires and Patient Cables | |
| 06/19/2000 | 2000V-1356 | Rock Capital Systems, Corp./Laser light show | |
| 06/20/2000 | 2000P-1352 | GensiaSicor Pharmaceuticals/ANDA Suitability Petition Camiodarone Hydrochloride Injectio | |
| 06/20/2000 | 2000V-1362 | Powerhouse Pro/Laser light show | |
| 06/21/2000 | 2000P-1355 | Consumer Healthcare Products Assoc/Labeling requirements for dietary supplements/St.John's wort | |
| 06/22/2000 | 2000P-1363 | Iceberg Industries Corporation (Canada)/To Amend 21 CFR 165.110 to include a Standard of Identity | |
| 06/22/2000 | 2000V-1358 | L'ecole de Ballet Arts Studio/Laser light show | |
| 06/23/2000 | 2000P-1365 | Lachman Consultants Services Inc/ANDA be submitted for Fluoxetine Tablets/40 mg | |
| 06/23/2000 | 2000P-1419 | Lachman Consultant Services Inc/ANDA for Gabapentin Tablets 100 mg 300 mg and 400 mg | |
| 06/27/2000 | 2000P-1369 | CSPI/Prohibit Making an Unapproved Health Claim | |
| 06/27/2000 | 2000P-1370 | Medeva Pharmaceuticals, Inc/ANDA for generic verions of Zaroxolyn Tablets(metolazone | DENIED 07/30/2003 Withdrawn 7/30/2003 |
| 06/27/2000 | 2000P-1371 | IOMED,Inc/Performance Standard for Electrode Lead Wires and Patient | |
| 06/28/2000 | 2000P-1372 | Allegiance Healthcare Corporation/Performance Standard for Electrode Lead Wires & Patient Cabl | |
| 06/28/2000 | 2000P-1375 | Lachman Consultant Services, inc./ANDA for Methimazole Tablets USP,20mg | |
| 06/28/2000 | 2000V-1376 | Mars 2112/Laser Light Show LM-10 Projection systems/spectra physics | |
| 06/28/2000 | 2000V-1377 | Mighty Ducks Hocky Club, Inc./Laser Light Show(2) LM-10 Micro Yag Projection systems | Approved 03/20/2006 |
| 06/28/2000 | 2000V-1381 | Daddy Rocks Inc/Laser Light Show | |
| 06/29/2000 | 2000P-0787 | Abbott Laboratories/Electrode Lead Wires/Patient Cables of 21 CFR part 898 | |
| 06/30/2000 | 2000P-1378 | CTFA/Cosmetic Products Containing Alpha Hydroxy Acids | |
| Top | |||
| July | |||
| 07/03/2000 | 2000V-1382 | Electronic Services Agency/AIG Limelight 200 & 45 Class IIIB Laser Diode Infrared Illum | |
| 07/06/2000 | 2000P-1397 | The Weinberg Group Inc/Cefaclor Chewable Tablets 500mg ANDA Suitability | |
| 07/13/2000 | 2000V-1398 | Micro Dot L.L.C./Laser light show | |
| 07/14/2000 | 2000P-1406 | Compressed Gas Assn/Nat Welding Supply/Stay Presenting, publishing promulgating "Fresh Air" Speeche | |
| 07/14/2000 | 2000V-1405 | Bon Secours South Country Heart Center/Telemetry transmitter cable | |
| 07/17/2000 | 2000P-1243 | Pharmaceutical Assoc Inc (PAI)/ANDA Suitability for Hydrocodone Bitartrate/Acetaminophen | Denied 05/07/2001 |
| 07/18/2000 | 2000P-1411 | CSPI/Set a regulatory limit for methylmercury in seafood | |
| 07/18/2000 | 2000V-1410 | B. E. Meyers & Co., Inc./Class IIIb requirements for the IZLID Series laser Products | |
| 07/18/2000 | 2000V-1417 | Biolase Technology, Inc./Twilite Dental Diode Laser | |
| 07/19/2000 | 2000V-1421 | Club M.K./Laser Light Show | |
| 07/20/2000 | 2000V-1420 | Deceptikon Visuals/Laser Light Show | |
| 07/20/2000 | 2000P-1422 | Yamanouchi Pharma Tecnologies Inc./Suitability Petition (OTC),Famotidine Orally Disintegrating | |
| 07/21/2000 | 2000V-1423 | Super Bowl/Laser Light Show | |
| 07/26/2000 | 2000V-1429 | Laser Wizardry/Laser Light Show | |
| 07/26/2000 | 2000V-1430 | Surround Design Accociates/Laser Light Show | |
| Top | |||
| August | |||
| 08/01/2000 | 2000P-1431 | Pharmaceuitcal Associates, Inc./ANDA for elixir containing 10mg hydrocodone bitartrate/650mg | |
| 08/02/2000 | 2000P-1432 | Paul Dowhal/Pregnancy Warning Language on OTC Nicotine Products | |
| 08/03/2000 | 2000P-1433 | Yamanouchi Pharma Technologies, Inc./ANDA for OTC drug product Famotidine orally disintegrating t | |
| 08/04/2000 | 2000V-1438 | Randy Johnson & Assoc/Laser Light Show | |
| 08/10/2000 | 2000P-1443 | Zenith Goldline Pharmaceuticals/Stay against approval of Alendronate Sodium Tablets | ANSWER 07/31/2003 answers PSA1 found in the docket |
| 08/10/2000 | 2000V-1442 | Yamagata Studio/Laser Light Show | |
| 08/11/2000 | 2000P-1445 | Zenith Goldline Pharmaceuticals/Paragraph IV ANDAs/180-Day Exclusivity Purporses | ANSWER 07/31/2003 |
| 08/11/2000 | 2000P-1446 | Teva Pharmaceuticals USA/Mylan Nifedipine extented-release tablets 30mg | |
| 08/11/2000 | 2000V-1450 | Celebration Park/Laser Light Show | |
| 08/14/2000 | 2000P-1452 | Cook Imaging Corporation/Supplement to Iopamidol Injection | |
| 08/14/2000 | 2000V-1453 | Disneyland Resort/Laser Light Show (Golden Dreams Laser Special Effects) | Approved 06/08/2005; Termination date 12/21/2008 |
| 08/14/2000 | 2000V-1454 | E-3/Laser Light Show, Mobolazer ML10-200,ML10-300,ML10-300W, | |
| 08/16/2000 | 2000V-1459 | Burning Man/Laser Light Show | |
| 08/17/2000 | 2000P-1462 | Lachman Consultant Services Inc./Extend Phenytoin Sodium Capsules | |
| 08/17/2000 | 2000V-1461 | DJ Distributors/Laser Light Show,ML10-200,ML10-300,ML10-300W,ML10-1.OG, | |
| 08/17/2000 | 2000V-1464 | Candyman Productions/Laser Light Show | |
| 08/18/2000 | 2000P-1466 | Pfizer, Inc./Non-Approvable Letters for Neurontin | Withdrawn 02/08/2006 |
| 08/18/2000 | 2000V-1465 | Family Bowling Center/Laser Light Show | |
| 08/18/2000 | 2000V-1473 | Steve Skrien/Laser Light Show | |
| 08/22/2000 | 2000P-1265 | Biosense Webster Inc/Performance standard for electrode lead wires & patient cabl | |
| 08/22/2000 | 2000P-1468 | Lachman Consultant Services, Inc./ANDA for Sertraline Hydrochloride Capsules 25mg, 50mg & 100m | |
| 08/22/2000 | 2000V-1469 | ZooBar,Inc/Laser Light Show | |
| 08/23/2000 | 2000P-1470 | Baxter Healthcare Corporation/ANDA 75-880 for 6%and10% PremaSol-sulfite-free (Amino Acid) | |
| 08/23/2000 | 2000P-1471 | GensiaSicor Pharmaceuticals/ANDA Suitability Petition Propofol Injectable Emulsion 2% | |
| 08/23/2000 | 2000P-1472 | Braintree Lab Inc/Over-the-counter sodium phosphate bowel preparation products | |
| 08/23/2000 | 2000V-1476 | My Generation/Laser light show | |
| 08/23/2000 | 2000V-1477 | Audio Line, Inc./Laser Light Show | |
| 08/23/2000 | 2000V-1478 | DJ Brat/Laser light show | |
| 08/28/2000 | 2000V-1479 | Dimension Seven/Laser Light Show | |
| 08/28/2000 | 2000V-1480 | Dino Quiroz/Laser Light Show | |
| 08/28/2000 | 2000V-1481 | Christopher Todd Aasen/Laser Light Show | |
| 08/28/2000 | 1975N-0183H | Woodward Laboratories, Inc./Health-Care Antiseptic Drug Products for OTC Human Use | |
| 08/29/2000 | 2000P-1486 | Equi Aid Products, Inc/ANADA Suitability Petition for a Generic Oral Ivermectin | |
| 08/29/2000 | 2000V-1490 | The Mens Club of Dallas/Laser Light Show | |
| 08/30/2000 | 2000P-1491 | Kraft Foods, Inc./Amend Definition & Standard of Identy for Parmesan Cheese | |
| 08/30/2000 | 2000V-1492 | Red Line Inc./Laser Light Show | |
| Top | |||
| September | |||
| 09/01/2000 | 2000P-1496 | Lachman Consultant Services,Inc./Gulucophage (Metformin HCI) Tablets, 625 mg and 750mg, | |
| 09/05/2000 | 2000P-1500 | Arnall Golden & Gregory LLP/Allow Dietary Supple Mfg to list ingredients aphabetically | |
| 09/06/2000 | 2000P-1499 | Public Citizen/Remove alosetron (Lotronex) from the market | Answered 02/12/2004 |
| 09/06/2000 | 2000P-1518 | PD Regulatory Services Inc/ANDA Suitability for Leucovorin Calcium Injection 5mg/ML | |
| 09/06/2000 | 1978N-0038 | Ciba Specialty Chemicals Corporation/Sunscreen Drug Products | |
| 09/08/2000 | 2000P-1329 | Consumer Healthcare Products Assoc (CHPA/Permit dietary supplement manufacturer to include the phrase | |
| 09/11/2000 | 2000P-1510 | CTS Chemical Industries, LTD (Israel)/Establish safety of Echinacea extract as a GRAS pharmaceutic | |
| 09/11/2000 | 2000V-1509 | Crystal Night Club/Laser Light Show | |
| 09/12/2000 | 2000P-1297 | Consumer Healthcare Products Assoc (CHPA/Permit an OTC drug mfg to include "may contain" in label | |
| 09/12/2000 | 2000V-1512 | Steve White/Laser light show | |
| 09/12/2000 | 2000V-1514 | Mainstream Music/Laser Light Show | |
| 09/15/2000 | 2000P-1519 | Smart Drug Systems Inc/ANADA for a generic new animal drug/Heartgard chewable tblts | |
| 09/19/2000 | 1999V-5521 | Pyro Magic Inc., DBA Laser Pyro Shows/Laser Light Show, SpectraScan LitePipe LP2-X Mobolazer | |
| 09/21/2000 | 2000P-1533 | Cook MED Institute, Incorporated/PTCA Balloon Catheters (74LOX) | |
| 09/22/2000 | 2000P-1535 | Boston Scientific Corporation/Biopsy forceps covers/non-electric biopsy as Class I devices | |
| 09/26/2000 | 2000V-1559 | B. C. T. Entertainment/Laser display device | |
| 09/27/2000 | 2000V-1544 | Kira LLC/Laser Light Show | |
| 09/28/2000 | 2000V-1546 | Linden Laser Systems/Laser Light Show | |
| 09/28/2000 | 2000V-1547 | John Coodey/John Coodey Laser Light Show | |
| 09/29/2000 | 2000P-1548 | Lachman Consultant Services, Inc./Neoral Soft Gelatin Capsules | |
| 09/29/2000 | 2000V-1552 | Pittsburgh Penguins Hockey Club/Laser light show | |
| 09/29/2000 | 2000V-1553 | Metropolis Theater/Laser light show | |
| Top | |||
| October | |||
| 10/02/2000 | 2000P-1550 | Glaxo Wellcome/Approve ANDA for Cefuroxime Axetil Products | |
| 10/02/2000 | 2000P-1551 | Arnall Golden & Gregory, LLP/Determine an ANDA may be submitted for a propxphene Napsylat | |
| 10/02/2000 | 2000V-1549 | Bulldent Inc. dba Our Place/Laser Light Show | Approved 10/31/2003; Terminates 10/26/2005 |
| 10/03/2000 | 2000P-1554 | Baxter Healthcare Corp/Exempt pharmacy compounding systems/Class II devices from PM | |
| 10/04/2000 | 2000P-1556 | Hyman Phelps & McNamara PC/Policy regarding ANDA holder confidentiality | |
| 10/10/2000 | 0/2000 | Paul E. Knapp/Health Hazard of "Radial" Sunglasses | |
| 10/12/2000 | 1999P-4053 | Mark P. Grath, Esq./Sympathominetic Amine Phentermine | |
| 10/13/2000 | 2000P-1564 | Alcon Research LTD./Grant a temporary exemption for one packaging component | |
| 10/16/2000 | 2000P-1568 | Lachman Consultant Services Inc/ANDA Suitability Petition for Ursodiol Oral Suspension | |
| 10/18/2000 | 2000P-1572 | State of Alaska/Adopt Standard of Identity for Bottled Glacier Water,Blend | |
| 10/20/2000 | 2000P-1574 | Recip AB, c/o R & R Registrations/ANDA Suitability Petition for Potassium Lodide 65 mg Tablets | |
| 10/20/2000 | 2000P-1577 | GE OEC Medical Systems, Inc./Variance from source-skin distance requirement of perf. std. | |
| 10/20/2000 | 2000V-1573 | Deja Vu of Washington Park/Laser Display Device | |
| 10/20/2000 | 2000V-1581 | Club Europe/Laser light show | |
| 10/23/2000 | 2000P-1578 | Michael R. Harbut, MD,MPH/Safety of Med.Devices Mfg. with Silicone Catalyzed w/ Hexach | |
| 10/23/2000 | 2000V-1576 | Insight Technology Incorporated/AN/PEQ-2A, Target Pointer-Illuminator/Aiming Light | Approved 10/20/06 |
| 10/23/2000 | 1976N-0052N | Public Citizen's Health Research Group/OTC Nasal Decongestants | |
| 10/23/2000 | 1981N-0022 | Public Citizen's Health Research Group/OTC Weight Control Drug Products for Human Use | |
| 10/24/2000 | 2000P-1580 | Lachman Consultant Services Inc/Listed drug withdrawn from sale; Drug product not marketed | |
| 10/25/2000 | 1995N-0304 | American Herbal Products Assn et al/Ephedrine Alkaloids: Reports of Adverse Events; Availability | |
| 10/30/2000 | 2000V-1588 | T & B Productions/Laser Light Show | |
| 10/30/2000 | 2000V-1589 | Quickbeam Systems Inc./Laser Light Show | |
| 10/30/2000 | 2000V-1590 | Sound Advice/Laser Light Show | |
| 10/31/2000 | 2000P-1594 | Highland Vet-Pharma, LLC/ANADA for Invermectin | |
| Top | |||
| November | |||
| 11/03/2000 | 2000P-1600 | SciReg, Inc./ANADA Suitability for Ivermectin | |
| 11/03/2000 | 2000P-1603 | American College of Obstetricians & Gyne/Rescind Any Contraindications For Use of Misoprostol In Preg | |
| 11/06/2000 | 2000P-1602 | New Jersey General Assembly/Remove Unapproved Children's Fluoride Supplements from Mkt | |
| 11/06/2000 | 2000V-1605 | Sam's Town Hotel and Casino/Laser Light Show | |
| 11/06/2000 | 2000V-1606 | U.S. Space and Rocket Center/Laser Light Show | |
| 11/07/2000 | 2000P-1607 | Chemically Associated Neurological Disor/Revoke Implantation of Silicone Gel-Filled Breast Implants | |
| 11/08/2000 | 2000V-1614 | Midwest Stereo/Laser Light Show | |
| 11/09/2000 | 2000P-1623 | American College of OB-GYN (ACOG)/WDL of letter issued regarding product Misoprostol | |
| 11/09/2000 | 2000V-1619 | Backwaters, Inc./Laser light show | |
| 11/09/2000 | 2000V-1622 | Opryland Hospitality & Attractions/Opryl/Laser light show | |
| 11/09/2000 | 1998P-0623 | Levin Fishbein Sedran & Berman/Revoke determination that TSRH Pedicle Spinal Screw System | |
| 11/13/2000 | 2000P-1617 | Ventro Corporation/Exemptions Requirements of 21 CFR E-commerce Products | |
| 11/13/2000 | 2000V-1624 | The Club at II Panino/Laser light show | |
| 11/13/2000 | 1978N-0038 | Playtex Products, Inc./Sunscreen Drug Products | |
| 11/15/2000 | 2000P-1621 | Lipomed, Inc./ANDA suitability for cladribine-lipomed 10 mg/5ml | |
| 11/15/2000 | 2000V-1627 | Gear Connection/Laser light show | |
| 11/16/2000 | 2000V-1626 | S L V/Laser Light Show | |
| 11/20/2000 | 2000P-1628 | Anthron Bethea/Insurance Matters Regarding Unemployment & Social Security | |
| 11/22/2000 | 2000A-1635 | Advocacy, Incorporated/Pharmacological Studies - Disability Antidiscrimination | |
| 11/24/2000 | 1997N-0314 | Jerome Stevens Pharmaceuticals Inc/Prescription Drug Products; Levothyroxine Sodium | |
| 11/27/2000 | 2000V-1656 | Russell C Davis Planetarium/Application for transfer of variance for laser light show | |
| 11/29/2000 | 2000P-1641 | Pharmaceutical Associates, Inc./ANDA Suitability for Combo Hydrocodone Bitartrate & Acetamin | |
| 11/29/2000 | 2000V-1643 | Wicked Angel Entertainment/Laser Light Show | |
| 11/30/2000 | 2000P-1645 | McKenna & Cuneo, L.L.P./ANDA for Mercaptopurine 100 mg Scored Oral Tablet | |
| 11/30/2000 | 2000V-1644 | Laser Billboard Corporation, Inc./Laser Light Show | |
| 11/30/2000 | 2000V-1646 | Eclipse/Laser Light Show | |
| 11/30/2000 | 2000V-1653 | Marathon Marketing, LLC/Laser light show | |
| Top | |||
| December | |||
| 12/04/2000 | 2000P-1648 | NeuroControl Corporation/Electrode Lead Wires and Patient Cables | |
| 12/04/2000 | 2000V-1647 | Lumatech Lighting/Laser Light Show | |
| 12/05/2000 | 2000P-1668 | CSPI/Action against mfrs&dists of garlic supplements misbranded | |
| 12/06/2000 | 2000P-1655 | HighlandVet-Pharma LLC/ANADA Application; Proposed product differ from appoved list | |
| 12/06/2000 | 2000P-1657 | Cintas Corp./Request for exemption to allow phrase "may contain" on conta | |
| 12/06/2000 | 2000V-1654 | Safety & Compliance Consulting/Laser Light Show | |
| 12/12/2000 | 2000V-1667 | TSI Incorporated/LS200 LaserSpeed Velocity Measurement System | |
| 12/14/2000 | 2000V-1670 | Pure Bar Room/Laser Light Show | |
| 12/15/2000 | 2000P-1671 | Pharmacists Planning Service, Inc./Patient Medicine Guides (MedGuides)/Cox-II & NSAID | |
| 12/18/2000 | 2000V-1673 | The DJ Store/Request for Laser Light Show | |
| 12/19/2000 | 2000P-1675 | Biosite Diagnostics, Incorporated/Triage B-Type Natriuetic Peptide (BNP) Test (K003475) | |
| 12/19/2000 | 2000P-1676 | Southwest Texas State University/Electrode Lead Wires and Patient Cables | |
| 12/20/2000 | 2000P-1491 | Sartori Foods Corporation ./Amend Definition & Standard of Identy for Parmesan Cheese | |
| 12/20/2000 | 2000P-1687 | Sartori Food Corp./Amend definition & standard of identity for parmesan cheese | |
| 12/21/2000 | 2000P-1680 | Protein Technologies International, Inc./Amending the Method of Calculating Protein Content | |
| 12/22/2000 | 2000V-1685 | Storm Theater Group at Mamdalay Bay/Laser Light Show Lasermedia | |
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