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...
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)-...
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...
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
Pharmaceutical Product List T-Z - Novartis.com Residents only) Printer friendly version Novartis.com home -| Contact -| Site Map -| Help -| Legal Disclaimer -| Privacy Policy © 2003 Novartis AG Pharmaceutical Product List T-Z - Novartis.com Pharmaceutical Product List T-Z - Novartis.com products, novartis, pharmaceuticals, pharmaceutical, Tearisol, dryness, eye, TearSaver, Tegretol, anticonvulsant, Tetracaine, Tofranil,...
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
C:\Sonny files\Team 2 Files\Ophthalmics\Zaditor\11415 06.18.03 VIOL\ Zaditor.doc Caballa Vice President Regulatory and Medical Affairs Novartis Ophthalmics 11694 Johns Creek Parkway Duluth, Georgia 30097 RE: NDA# 21- 066 Zaditor (ketotifen fumarate ophthalmic solution), 0.025% MACMIS ID# 11415 Dear MsZaditor as a better option: ° "If allergy pills aren't enough for your itchy eyes… try Zaditor ...
author: Sonny Saini
C:\Sonny files\Team 2 Files\Ophthalmics\Zaditor\11415 06.18.03 VIOL\ Zaditor.doc page 1
author: Sonny Saini
http://www.fda.gov/cder/foi/appletter/2001/21066s4ltr.pdf page 1
author: Joanne Holmes
Zaditor Consumer Information Zaditor ® Brand Name: Zaditor ® Active Ingredient: - ketotifen fumarate Strength(s): 0.025% Dosage Form(s): - Ophthalmic solution Company Name: -- Ciba Vision, A Novartis Company Availability: ------- Prescription only *Date Approved by the FDA: - July 7, 1999 *Approval by FDA does not mean that the drug is available to consumers at this time
CDER 1999 Report to the Nation 1999 new molecular entities: Alitretinoin (Panretin) Aminolevulinic acid hydrochloride (Levulan Kerastick) Amprenavir (Agenerase) Bexarotene (Targretin) Cilostazol (Pletal) Dalfopristin/ quinupristin (Synercid) Dexmedetomidine hydrochloride (Precedex) Dofetilide (Tikosyn) Doxercalciferol (Hectorol) Entacapone (Comtan) Epirubicin hydrochloride (Ellence) Exemestane (Aromasin)...
author: Center for Drug Evaluation and Research
subject: Improving Public Health Through Human Drugs
CDER 1999 Report to the Nation page 13
author: Center for Drug Evaluation and Research
subject: Improving Public Health Through Human Drugs
CDER 1999 Report to the Nation page 11
author: Center for Drug Evaluation and Research
subject: Improving Public Health Through Human Drugs
IM6991.PDF page 3
author: Unknown
IM6991.PDF page 2
author: Unknown
