Antihistamines for allergic rhinitis - [Medication] - Quest Diagnostics Patient Health Library Newer prescription (second-generation) antihistamines Brand Name Chemical Name Clarinex desloratadine Cetirizine hydrochloride (Zyrtec) and desloratadine (Clarinex) are available in pill and liquid form.Desloratadine is also available as "Reditabs," small tablets that dissolve on the tongue.Desloratadine (Clarinex ) is approved for seasonal...
http://www.biosis.org/ts/media/cdjournals/gazettenews/2003/CPG_News_0343.pdf week 0343 24 Oct 2003 AstraZeneca has claims to a range of histone deacetylase (HDAC) inhibitors, possibly a new target for the company Drug Patenting in Context A five-year period of extended protection under SPC/GB97/091 began on September 23 rd 2003 for Fujisawa’s cefdinir.
Gazette Highlights News 2003 - Thomson Scientific Thomson.com - - - - - Advanced Search - - - EN : JP : CN : KR -- - - Thomson Scientific : Gazette Weekly Highlights News : Gazette Highlights News 2003 - Gazette Highlights News 2003 Click on a week to view more Week 51: This issue of Current Patents Gazette is the final one for 2003...Desloratadine, Schering's antihistaminic, marketed in the US as Clarinex, is the...
Approved Products_2004.xls LIST OF APPROVED BIOTECHNOLOBY PRODUCTS (Page 1: product 1- 50) Biotechnology companies have already commercialized a great number of drugs.Clarinex Desloratadine Claritin Isomer Aller gic Rhinitis Sepracor 185 Jan- 02 Eli gard Leuprolid acetate Advanced prostate cancer Atrix Laboratories 186 Jan- 02...
author: Reijer
Approved Products_2004.xls page 4
author: Reijer
Database C C - investigational drugs, therapies and vaccines # - A - B - C - D - E - F - G - H - I - J - K - L - M - N - O - P - Q - R - S - T - U - V - W - X - Y - Z From this page you may order documents with information covering investigational products.
Database D D - investigational drugs, therapies and vaccines # - A - B - C - D - E - F - G - H - I - J - K - L - M - N - O - P - Q - R - S - T - U - V - W - X - Y - Z From this page you may order documents with information covering investigational products.
http://www.fda.gov/cder/orange/appendix_a.txt 3, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE PHOSPHATE #3, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE PHOSPHATE, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE, ACETAMINOPHEN ACETAMINOPHEN, ACETAMINOPHEN (OTC) ACETAMINOPHEN, ASPIRIN AND CAFFEINE, ACETAMINOPHEN (OTC) ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE, ACETAMINOPHEN ACETAMINOPHEN, BUTALBITAL AND CAFFEINE, ACETAMINOPHEN ACETAMINOPHEN,...
Drug Approval Package Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Clarinex (Desloratadine) Tablets Company:--Schering Corp
author: USERNAME
Clarinex (Desloratadine) Tablets Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Clarinex (Desloratadine) Tablets Company:--Schering Corporation Application No.:--21-165 Approval Date:-12/21/2001 - Approval Letter(s) - Printed Labeling - Medical Review(s) Part 1 - Part 2 -- Chemistry Review(s) - Pharmacology Review(s)- Part 1 -- Part 2 -- Part 3 - Part...
author: Paul Stauffer
../2002/21-363_Clarinex Tablets Food and Drug Administration • Center for Drug Evaluation and Research Title Search Clarinex (Desloratadine) Tablets Company:--Schering Corporation Application No.:--21-363 Approval Date:-2/8/02 Approval Letter(s) - Printed Labeling - Medical Review(s)- Part 1 - Part 2 - Chemistry Review(s) - Pharmacology Review(s)- Part 1 - Part 2 - Part 3 - Part 4 - Part 5 -...
author: USERNAME
../2002/21-297_Clarinex Tablets Food and Drug Administration • Center for Drug Evaluation and Research Title Search Clarinex (Desloratadine) Tablets Company:--Schering Corporation Application No.:--21-297 Approval Date:-2/8/02 Approval Letter(s) - Printed Labeling - Medical Review(s)- Part 1 - Part 2 - Chemistry Review(s) - Pharmacology Review(s)- Part 1 - Part 2 - Part 3 - Part 4 - Statistical...
author: USERNAME
CDER Report to the Nation: 2001 New molecular entities Almotriptan malate (Axert) Bimatoprost (Lumigan) Bosentan (Tracleer) Caspofungin acetate (Cancidas) Cefditoren pivoxil (Spectracef) Desloratadine (Clarinex) Drospirenone/ethinyl estradiol (Yasmin) Dutasteride (Dutasteride) Ertapenem sodium (Invanz) Etonogestrel/ethinyl estradiol (NuvaRing) Fondaparinux sodium (Arixtra) Formoterol fumarate (Foradil...
author: OLIVERN
NDA Approvals for Calendar Year 2001 Braun 5 S 21-Feb-01 21-235 Prozac Weekly Fluoxetine Hydrochloride Eli Lilly 3 S 26-Feb-01 21-169 Reminyl Galantamine Hydrobromide Janssen Research 1 S 28-Feb-01 21-082 Tavist Allergy/Sinus/Headache Acetaminophen/Clemastine Fumarate/Pseudoephedrine Hydrochloride Novartis 4 S 01-Mar-01 21-257 Travatan Travoprost Alcon 1 P 16-Mar-01 21-262 Alphagan P Brimonidine Tartrate Allergan 3 S 16...
author: Brenda Harmon
FDA Drug Approvals List December 2001 - Drug Approvals for December 2001 Definitions and Notes Original New Drug Applications Original Application #: 021165 Approval Date: 21-DEC-01 Trade Name: CLARINEX Chemical Type: 1 Therapeutic Potential: S Dosage Form: TABLET Applicant: SCHERING PLOUGH CORP Active Ingredient(s): DESLORATADINE OTC/RX Status: RX Indication(s): For the relief of the nasal and non-nasal...
FDA Drug Approvals List June 2002 - Drug Approvals for June 2002 Definitions and Notes Original New Drug Applications Original Application # 021316 Approval Date: 26-JUN-02 Trade Name: ALTOCOR Chemical Type: 3 Therapeutic Potential: S Dosage Form: TABLET Applicant: AURA LABORATORIES INC Active Ingredient(s): LOVASTATIN OTC/RX Status: RX INDICATION OF USE: For lowering total cholesterol and LDL-C to target levels as...
FDA Drug Approvals List February 2002 - Drug Approvals for February 2002 Definitions and Notes Original New Drug Applications Original Application #: 020982 Approval Date: 12-FEB-02 Trade Name: PAXIL CR Chemical Type: 6 Therapeutic Potential: S Dosage Form: TABLET Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS Active Ingredient(s): PAROXETINE HYDROCHLORIDE OTC/RX Status: RX Indication(s): For the treatment of Panic...
Prescription and OTC Drug Product List 12/2001 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE CAPSULE; ORAL SYNALGOS-DC-A -A- @ WOMEN FIRST HLTHCARE 356.4MG;30MG;16MG N89166 001 MAY 14, 1986 DEC CAHN -D- @ WYETH AYERST 356.4MG;30MG;16MG N89166 001 MAY 14, 1986 DEC CAHN ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL ANEXSIA 5/325 -D- AA MALLINCKRODT 325MG;5MG N40409...
Prescription and OTC Drug Product List 6/2002 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -D- AA PEACHTREE 500MG;10MG N40210 001 AUG 13, 1997 JUN CAHN -A- AA UCB 500MG;10MG N40210 001 AUG 13, 1997 JUN CAHN ACETAMINOPHEN; PROPOXYPHENE HYDROCHLORIDE TABLET; ORAL DARVOCET -A- @ AAIPHARMA LLC 325MG;32.5MG N16844 001 JUN CAHN -D- @...
Document Information Page The chemical name is 8- chloro- 6,11- dihydro- 11-( 4- piperdinylidene)- 5Hbenzo[ 5,6] cyclohepta[ 1,2- b] pyridine and has the following structure: CLINICAL PHARMACOLOGY: Mechanism of Action: Desloratadine is a long- acting tricyclic histamine antagonist with selective H1- receptor histamine antagonist activityDesloratadine pharmacokinetics were...
author: Christine Yu
Document Information Page page 2
author: Christine Yu
Document Information Page page 1
author: Christine Yu
Efficacy Supplements Approved in Calendar Year 2002 (SE1-SE7 AND SE8s EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR 2002 (SE1 -SE7)* and EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR 2002 (SE8)* - GENERIC NAME APPLICANT NDA NUMBER SUPP TYPE SUPP NUMBER RECEIPT DATE APPROVAL DATE PRIORITY REVIEW- TOTAL APPROVAL TIME (MONTHS) INDICATION/DESCRIPTION ANASTROZOLE ASTRAZENECA 20-541 SE1 010 5-Mar-02 5-Sep-02 Y 6.0 Provides for the use of ARIMIDEX ...
author: Darlene Norris
21-165 S-001 AP CLARINEX.pdf Distribution: Desloratadine and 3- hydroxydesloratadine are approximately 82% to 87% and 85% to 89%, bound to plasma proteins, respectivelyDesloratadine and 3- Hydroxydesloratadine Pharmacokinetics in Healthy Male and Female Volunteers Desloratadine 3- Hydroxydesloratadine Cmax AUC 0- 24 hrs Cmax AUC 0- 24 hrs Erythromycin (500 mg Q8h) + 24% ...
author: gracej
21-165 S-001 AP CLARINEX.pdf page 13
author: gracej
duplicates:http://www.fda.gov/cder/foi/label/2002/21363lbl.pdf http://www.fda.gov/cder/foi/label/2002/21297lbl.pdf
