FDA Drug Approvals List December 2001
Active Ingredient(s): LISINOPRIL OTC/RX Status: RX Original Abbreviated Application #: 076058 Tentative Approval Date: 21-DEC-01 Trade Name: MIDAZOLAM HCL Dosage Form: SYRUP Applicant: RANBAXY LABORATORIES LTD Active Ingredient(s): MIDAZOLAM HYDROCHLORIDE OTC/RX Status: RX Original Abbreviated Application #: 076134 Tentative Approval Date: 20-DEC-01 Trade Name: LORATADINE Dosage Form...
http://www.fda.gov/cder/otcmonographs/Oral_Health_Care/gingivitis_&_plaque_PR_20030529.htm
------------------------------------------------------------------------ Colgate -Palmolive Co., Piscataway, Colgate Tartar Control Toothpaste, NJ 08855 Gelkam Oral Care Rinse, Dentaguard Toothpaste Active Ingredients Submitted For Review Labeled Ingredients Contained in Marketed Products Submitted to the Subcommittee: Alkyl dimethyl amine oxide Alkyl dimethyl glycine...
DDPA January 1996
20-454 ZANTAC 150 GLAXO WELLCOME RANITIDINE HYDROCHLORIDE 02-JAN-96 (TABLET, CHEWABLE) RES TRIANGLE PK, NC EQ 150MG BASE 27709 (HISTAMINE H-2 RECEPTOR ANTAGONIST) 20-497 FARESTON ORION TOREMIFENE CITRATE 03-JAN-96 (TABLET) ESPOO, FINLAND EQ 60MG BASE (NONSTEROIDAL ANTIESTROGEN) 20-552 COVERA-HS SEARLE VERAPAMIL HYDROCHLORIDE 17-JAN-96 (TABLET, SKOKIE, IL 180MG EXTENDED RELEASE) 60077...
Drug Approvals September 1996
CATARRHALIS TO THE INDICATIONS AND USAGE SECTION Approvable Original New Drug Applications Original Application #: 020535 Approvable Date: 30-SEP-96 Trade Name: DURACT Dosage Form: CAPSULE Applicant: WYETH AYERST LABORATORIES INC Active Ingredient(s): BROMFENAC SODIUM OTC/RX Status: RX Original Application #: 020690 Approvable Date: 19-SEP-96 Trade Name: ARICEPT Dosage Form: TABLET...
Drug Approvals for July 1997
Drug Approvals for July 1997 Definitions and Notes July 1997 Original New Drug Applications Original Application #: 020701 Approval Date: 31-JUL-97 Trade Name: CRINONE Chemical Type: 3 Therapeutic Potential: S Dosage Form: GEL Applicant: COLUMBIA RESEARCH LABORATORIES INC Active Ingredient(s): PROGESTERONE OTC/RX Status: RX Indication(s): Treatment of secondary amenorrhea Original...
Cancer.gov - Oral Complications of Chemotherapy and Head/Neck Radiation (PDQ®)
Degree of damage is dependent on treatment regimen-related factors including type of radiation used, total dose administered, and field size/fractionation Risk for radiation-induced chronic complications is related to the total dose and schedule of radiation therapyFluoride recommendedFluoride: 1.1% neutral sodium fluoride gel Use of total ...
Document page 53
author: U.S. Government Printing Office
subject: Extracted Pages
510(k)s Final Decisions Rendered
SE DECISION MADE: 15-MAR-00 TEWKSBURY, MA 01876 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NUPRO PROPHYLAXIS PASTE WITH FLUORIDE AND TRICLOSAN DENTSPLY INTL SE DECISION MADE: 07-MAR-00 AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERICHEK TOTAL CHLORINE REAGENT STRIPS ENVIRONMENTAL TEST SYSTEMS, INC 510(k) NO: K000091 (TRADITIONAL) ATTN: TERRY...
author: OSM/DID
Antibiotics/antimicrobials for gum disease - [Medication] - Quest Diagnostics Patient Health Library
Antibiotics/antimicrobials for gum disease Examples Brand Name Chemical Name - penicillin - clindamycin - metronidazole Peridex, Periogard chlorhexidine gluconate Periostat doxycycline hyclate Colgate Total toothpaste triclosan Atridox doxycycline hyclate PerioChip chlorhexidine gluconate Arestin minocycline Sustained-release antibiotics Brand Name Chemical Name...
http://www.fda.gov/cder/foi/appletter/2003/20231scf028ltr.pdf page 1
author: ABRAHAM
http://www.fda.gov/cder/orange/appendix_a.txt
12, CHLORPHENIRAMINE MALEATE (OTC) CODOXY, ASPIRIN CODRIX, ACETAMINOPHEN COGENTIN, BENZTROPINE MESYLATE COGNEX, TACRINE HYDROCHLORIDE COL-PROBENECID, COLCHICINE COLAZAL, BALSALAZIDE DISODIUM COLBENEMID, COLCHICINE COLD CAPSULE IV, CHLORPHENIRAMINE MALEATE (OTC) COLD CAPSULE V, CHLORPHENIRAMINE MALEATE (OTC) COLESTID, COLESTIPOL HYDROCHLORIDE COLGATE TOTAL, SODIUM ...
Training requirements for medicines counter assistants
Aciclovir Acrivastine Alcohol Alginates Almond oil Aluminium Arachis oil Aspirin Azelastine Beclometasone Benzalkonium Benzocaine Benzoyl peroxide Bisacodyl Buclizine Caffeine Calcium Cetirizine Cetrimide Cetylpyridinium Chlorhexidine Chlorphenamine Cimetidine Cinnarizine Clotrimazole Coal Tar Codeine Crotamiton Dequalinium Dextromethorphan Dihydrocodeine Dimeticone Diphenhydramine...
Training requirements for medicines counter assistants page 3
Regulation of dispensing/pharmacy assistants: Minimum competence requirement
Aciclovir Acrivastine Alcohol Alginates Almond oil Aluminium Arachis oil Aspirin Azelastine Beclometasone Benzalkonium Benzocaine Benzoyl peroxide Bisacodyl Buclizine Caffeine Calcium Cetirizine Cetrimide Cetylpyridinium Chlorhexidine Chlorphenamine Cimetidine Cinnarizine Clotrimazole Coal Tar Codeine Crotamiton Dequalinium Dextromethorphan Dihydrocodeine Dimeticone Diphenhydramine...
Regulation of dispensing/pharmacy assistants: Minimum competence requirement page 5
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt
"HOMATROPINE HYDROBROMIDE, MANUFACTURED IN INGELHIEM/RHEIN, GERMANY" 12068 31-Jul-96 MULTIPLE PEPTIDE SYSTEMS "P-113 SYNTHETIC PEPTIDE, MANUFACTURED IN SAN DIEGO, CA" 12072 05-Aug-96 LIANYUNGANG PHARMACEUTICAL FACTORY "MESNA, MANUFACTURED IN JIANGSU PROVINCE, PEOPLE'S REPUBLIC OF CHINA" 12074 06-Aug-96 PTI ADVANCED FILTRATION INC "PROFLOW II, MANUFACTURED IN NEWBURY, CALIFORNIA"...
Document4
9 Through this procedure, it has been shown that Gantrez Copolymers when included in dentifrices with triclosan, enhance the retention of triclosan onto oral hard and soft tissue 9 We have modified this in vitro procedure (Schematic 1) and extended the technology to show that Gantrez is effective at enhancing the buccal retention of not only triclosan, but also a...
author: Michelle Evans
Document4 page 17
author: Michelle Evans
ISP: Oral Care
TOOTHPASTE AND MOUTHWASH Tartar Control Tartar build-up on teeth continues to be a world-wide problem in maintaining good oral health 1 Later studies showed that, although pyrophosphate is effective in vitro, it is readily broken down by neutral, acidic, and alkaline phosphatases in the mouth As highly effective inhibitors of alkaline phosphatases, 5 ISP's Gantrez S copolymers...
ISP POLYMERS FOR ORAL CARE
Applications TOOTHPASTE AND MOUTHWASH Tartar Control Tartar build-up on teeth continues to be a world-wide problem in maintaining good oral health Muhlemann, H.; Koning, K.; and Marthaler, T.M.; "The Cariostatic Effect of Sodium Fluoride when Combined with Phosphates"; Helv Odonta Acta, 5, 4-8 (1961) 3 Gaffar, A.; Esposito, A.; Afflitto, J.; "In vitro and In-vivo...
Oral Care Brochure.qxd page 13
author: Michelle Evans
Cels0146 page 3
Triclosan MR Broth Escherichia coli 24 Dentifrice Pseudomonas aeruginosa 24 Staphylococcus aureus 24 Candida albicans 24 Aspergillus niger 27 To enhance the recovery of S. aureus, different enrichment broths were analyzed. The R Broth was modified (MR) by increasing the concentration of Tween ...
author: Scott Sutton
Cels0146 page 2
low endogenous ATP, and no enhancement/ inhibition effect on the ATP bioluminescence reaction. The final step in validating the Celsis ATP Bioluminescence Assay is to add various levels of different types of microorganisms to the 1% dentifrice suspensions to ensure detection of microbial growth. ...
author: Scott Sutton
Cels0146 page 1
1997 ASM Meeting Paper No. Q 46 Optimization of the Celsis ATP Bioluminescence Assay for the Detection of Microbial Contamination in Triclosan and High Fluoride Dentifrices Raymond Ignar, Donald English and Luis Jimenez Microbiology Laboratory, Research and Development, Block Drug Company, ...
author: Scott Sutton
http://www.fda.gov/cder/foi/appletter/2003/20231scp032ltr.pdf page 1
author: ABRAHAM