Drug Approvals - Z Product Name Company Application # Approval Date Letter Posted Label Posted Review Posted ZADITOR (ketotifen fumarate ophthalmic solution) 0.025%, Rx Ciba Vision NDA 21-066 7/2/99 7/6/99 7/6/99 3/31/02 ZADITOR (ketotifen fumarate ophthalmic solution) 0.025%, Rx Ciba Vision NDA 21-066/S4 07/20/01 05/08/03 - ZADITOR Indication: for the prevention of itching of the eye due...
http://www.fda.gov/cder/orange/appendix_a.txt 4, ACETAMINOPHEN TYLENOL W/ CODEINE, ACETAMINOPHEN TYLENOL, ACETAMINOPHEN (OTC) TYLOX, ACETAMINOPHEN TYLOX-325, ACETAMINOPHEN TYMTRAN, CERULETIDE DIETHYLAMINE TYZINE, TETRAHYDROZOLINE HYDROCHLORIDE TZ-3, TIOCONAZOLE (OTC) ** U ** U-CORT, HYDROCORTISONE ACETATE U-GENCIN, GENTAMICIN SULFATE UCEPHAN, SODIUM BENZOATE ULO, CHLOPHEDIANOL HYDROCHLORIDE ULTANE, SEVOFLURANE ULTIVA,...
NMEs Approved in CY 1999 NMEs Approved in Calendar Year 1999 NDA Number Generic Name- Trade Name Dosage Form Applicant - --- Classification- Approval Date - - - - - - - 20-863 Cilostazol Pletal Tablet Otsuka Pharm 1S 01-15-1999 20-886 Alitretinoin Panretin Topical Gel Ligand Pharm 1-PV 02-02-1999 20-955 Sodium Ferric Gluconate Complex Ferrlicit Injectable R&D Labs 1P 02-18-1999 21-007 Amprenavir Agenerase...
author: Elaine Abraham
FDA Drug Approvals List July 2001 PERRIGO COMPANY Active Ingredient(s):ACETAMINOPHEN; ASPIRIN;CAFFEINE OTC/RX Status: RX Labeling Supplements to Original New Drug Applications Application #: 019906 Labeling Supplement#: 009 To Original New Drug Application Approval Date: 31-JUL-01 Trade Name: ANAFRANIL Dosage Form: CAPSULE Applicant: NOVARTIS PHARMACEUTICALS CORP Active Ingredient(s): CLOMIPRAMINE HYDROCHLORIDE OTC...
../99/21-066_ZADITOR%200.025%25_ Food and Drug Administration • Center for Drug Evaluation and Research Approval Package [http://www.fda.gov/cder/templates/2ndrow-component.htm] [http://www.fda.gov/cder/templates/sidebar-component.htm] Zaditor (Ketotifen Fumarate) Ophthalmic Solution Company:--Ciba Vision - A Novartis Company Application No.:--21-066 Approval Date:-7/2/1999 Approval Letter(s) -...
author: Paul Stauffer
FDA Drug Approvals List March 2000 Original Application #: 021124 Approval Date: 17-MAR-00 Trade Name: LAMISIL Chemical Type: 6 Therapeutic Potential: S Dosage Form: SOLUTION Applicant: NOVARTIS PHARMACEUTICALS CORP DBA SANDOZ PHARMACEUTICALS CORP Active Ingredient(s): TERBINAFINE HYDROCHLORIDE OTC/RX Status: RX Indication(s): For the treatment of interdigital-type pedis (athlete’s foot), tinea cruris (jock itch)...
FDA Drug Approvals List July 1999 Drug Approvals for July 1999 Definitions and Notes Original New Drug Applications Original Application #: 021057 Approval Date: 29-JUL-99 Trade Name: ANTAGON Chemical Type: 1 Therapeutic Potential: P Dosage Form: INJECTABLE Applicant: ORGANON INC Active Ingredient(s): GANIRELIX ACETATE OTC/RX Status: RX Indication(s): Provides for the inhibition of premature LH surges in women...
IM6991.PDF Page 1 ZADITOR™ ketotifen fumarate ophthalmic solution, 0.025% DESCRIPTION ZADITOR™ is a sterile ophthalmic solution containing ketotifen for topical administration to the eyesKetotifen Fumarate Ophthalmic Solution CHEMICAL NAME 4-( 1- Methyl- 4- piperidylidene)- 4H- benzo[ 4,5] cyclohepta[ 1,2- b] thiophen- 10( 9H)- one...
author: Unknown
IM6991.PDF page 1
author: Unknown
Pharmaceutical Product List T-Z - Novartis.com Search Novartis.com - Go Novartis.com Home Products Pharmaceutical Best Sellers Pharmaceuticals CIBA Vision Animal Health Over the Counter Infant and Baby Medical Nutrition Diseases & Conditions About Novartis Investor Relations Media Relations Careers Corporate Citizenship Business Development Our Mission Our Businesses Leadership & Governance Research & Development Foundations...
LeadDiscovery - Therapeutic Advances - 2003 Archive - - - - BioNews BioWeb Companies Products BioReports - - - - - Channels Select Channel -------> Channels Home Page BioWeb Search BioNews Search BioNews Topics BioWatch Tracking BioJob Career Bio/Pharma Events BioNewsCast BioCorporate BioReports Indication/Disease BioZak CD-rom BioTechnologies BioExecutive BioEquities/Stocks BioDrug Discovery BioJournal BioAnalysis BioSuppliers...
Ketotifen widens the therapeutic window of doxorubicin - - - - BioNews BioWeb Companies Products BioReports - - - - - Channels Select Channel -------> Channels Home Page BioWeb Search BioNews Search BioNews Topics BioWatch Tracking BioJob Career Bio/Pharma Events BioNewsCast BioCorporate BioReports Indication/Disease BioZak CD-rom BioTechnologies BioExecutive BioEquities/Stocks BioDrug Discovery BioJournal BioAnalysis BioSuppliers...
LeadDiscovery - Therapeutic Advances - Focus on Cell Death - - - - BioNews BioWeb Companies Products BioReports - - - - - Channels Select Channel -------> Channels Home Page BioWeb Search BioNews Search BioNews Topics BioWatch Tracking BioJob Career Bio/Pharma Events BioNewsCast BioCorporate BioReports Indication/Disease BioZak CD-rom BioTechnologies BioExecutive BioEquities/Stocks BioDrug Discovery BioJournal BioAnalysis BioSuppliers...
Table of Contents The development of novel small molecule XIAP inhibitors with anti-cancer activity The MLK inhibitor, CEP11004: A candidate for the treatment of Parkinson’s disease ABPD: An optimized retinoid with RAR-dependent and independent activity Mechanisms of apoptosis in Alzheimers disease Protein kinase C delta (PKC delta) inhibitors as a target for pro-apoptotic treatment of cancer...
Novartis Press Kit English page 25
author: guestnc1
duplicates:http://www.novartis.com/downloads/press_kit.pdf
2003 Warning Letters and Untitled Letters to Pharmaceutical Companies Food and Drug Administration • Center for Drug Evaluation and Research Compliance Activities Search Warning Letters and Untitled Letters to Pharmaceutical Companies 2003 These letters, sorted by month, are supplied by the CDER Freedom of Electronic Information Office
author: STAUFFERP
Maximum Recommended Therapeutic Dose (MRTD) Database Maximum Recommended Therapeutic Dose (MRTD) Database (1,235 pharmaceuticals) A -- B- - C -- D -- E -- F-G -- H-K -- L -- M -- N -- O -- P -- Q-R -- S -- T -- U-Z MRTD--- (mg/kg--- bw/day) -- Generic Chemical Name Chemical Structure (SMILES Code) 3.00000-- Acemetacin C1=C(OC)C=C3C(=C1)N(C(=O)C2=CC=C(Cl)C=C2)C(C)=C3CC(=O)OCC(O)=O 0.20000-- Acenocoumarol C1=CC=C3C(=C1)OC(=O)C(C(CC(C)=O...
Product Description OTC CATALOGUE SEARCH PRODUCT PRODUCTS FAQ (CONSUMERS) NEW PRODUCTS FAMILY HEALTH CORNER WOMEN'S HEALTH ALLERGIES COUGH, COLD pms-KETOTIFEN Part Code : 5760616809 Therapeutic Class : Pediatric Asthma prophylactic-Antiallergic agent Product Class : Pharmaceuticals Compares to : Zaditen Form : Tablets Strength : 1mg Format : 250mL UPC : 057606168092 DIN : 02231680 Click here to...
Product Description OTC CATALOGUE SEARCH PRODUCT PRODUCTS FAQ (CONSUMERS) NEW PRODUCTS FAMILY HEALTH CORNER WOMEN'S HEALTH ALLERGIES COUGH, COLD pms-KETOTIFEN Part Code : 5760616796 Therapeutic Class : Pediatric Asthma prophylactic-Antiallergic agent Product Class : Pharmaceuticals Compares to : Zaditen Form : Liquid Strength : 1mg/5mL Format : 100 UPC : 057606167965 DIN : 02231679 Click here to...
Search Products OTC CATALOGUE SEARCH PRODUCT PRODUCTS FAQ (CONSUMERS) NEW PRODUCTS FAMILY HEALTH CORNER WOMEN'S HEALTH ALLERGIES COUGH, COLD - - Click here to print -- (11 records found) PART CODE STRENGTH - THERAPEUTIC CLASS FORMAT - DESCRIPTION pms-KETOTIFEN 5760616796 1mg/5mL - Pediatric Asthma prophylactic-Antiallergic agent 100 - Clear, colorless liquid- 5760616809 1mg - Pediatric Asthma...
Pharmaceutical Product List T-Z - Novartis.com - Tetracaine (tetracaine hydrochloride) Used in procedures in which topical anesthesia is desired - TofranilA® (imipramine hydrochloride, pamoate-tricyclic antidepressan t) Used in treatment of antidepressant - TrasicorA® (oxprenolol-cardioprotective I²-blocker) Used in treatment of hypertension, angina pectoris and disturbances of cardiac rhythm - TrasitensinA® ...
Reference Listed Drug Labeling Approved in March 2000 TRADENAME ACTIVE/DOSAGE FORM NDA# SUPP# FIRM MAR DIOVAN HCT Valsartan/HCTZ/tab 20-818 S-006 Novartis Pharms 1 TIMOPTIC in OCCUDOSE Timolol maleate/opth.sol 19-463 S-020 Merck 2 EFFEXOR Venlafaxine HCl 20-151 S-014 Wyeth Ayerst 3 EFFEXOR XR Venlafaxine HCl 20-699 S-008 Wyeth Ayerst 3 TECZEM Diltiazem malate/enalapril maleate 20-507 S-002 Aventis Pharms 3 PROPULSID Cisapride/oral sol...
author: USERNAME
Reference Listed Drug Labeling Approved in July 2001 Jul 1 ESTROSTEP 21 letter label norethindrone acetate/ethinyl estradiol tablets 20-130 S-007 Jul 2 ACTOS letter - pioglitazone HCl tablets 21-073 S-011 SANDOSTATIN SANDOSTATIN LAR letter - octreotide acetate injection octreotide acetate injectable suspension 19-667 21-008 S-038 S-003 Jul 3 PROTONIX IV letter - pantoprazole sodium for injection 20-988 S-004 Jul 9 NICOTROL letter -...
author: USERNAME
Report to the Nation: Drug Review Priority new drug approvals: Alitretinoin Amprenavir (2 dosage forms) Aspirin/extended release-dipyridamole Bexarotene Busulfan Caffeine citrate Cytarabine liposome Dalfopristin/quinupristin Epirubicin hydrochloride Ganirelix acetate Ketotifen fumarate Levonorgestrel Nedocromil sodium Nitric oxide Orlistat Oseltamivir phosphate Pemirolast potassium Pioglitazone hydrochloride...
author: OLIVERN
Contents Vol. 23, No. 9, 2003 9, 2003 Contents Review Article Dose and Frequency of Administration of Interferon- 551- 559 Affect its Efficacy in Multiple Sclerosis MK Sharief Original Research Clinical Benefits with Oseltamivir in Treating Influenza in 561- 569 Articles Adult Populations: Results of a Pooled and Subgroup Analysis S Singh, J Barghoorn, A Bagdonas, J Adler, J Treanor, N Kinnersley, P Ward Long-...
author: Adis International Limited
subject: Clinical Drug Investigation
