Prevention and cessation of cigarette smoking: control of tobacco use: Prevention - Health Professional Information [NCI PDQ] - Despite high rates of recidivism at 1 year, the positive effect of the intervention persisted (19.6%-23.1% for the bupropion groups compared with 12.4% for placebo).[ 18 ] In another controlled trial, 244 subjects received bupropion only, 244 subjects received a nicotine patch, 245 subjects received both, and 160 subjects received placebo.[ 19 ] Interventions lasted 8 to...
Teva Pharmaceutical Industries - News and PR - - Search Tevapharm: - - Press Release Teva Signs Agreement With Andrx and Impax for Generic Formulations of Wellbutrin ® Sr and Zyban® Jerusalem, Israel,, July 31, 2003 - Teva Pharmaceutical Industries Ltd.Wellbutrin ® SR and Zyban® (...
Teva Pharmaceutical Industries - News and PR - - Search Tevapharm: - - Press Release Teva Commences Commercial Launch Of Bupropion 150 Mg Jerusalem, Israel, March 22, 2004 - Teva Pharmaceutical Industries Ltd.Bupropion Hydrochloride 150 mg...
Paragraph IV Patent Certifications - DRUG NAME DOSAGE FORM STRENGTH RLD Acetaminophen Extended-release Tablets 650 mg Tylenol Acetaminophen/ Aspirin/ Caffeine Tablets 250 mg/250 mg/ 65 mg Excedrin (migraine) Acetaminophen and Tramadol Hydrochloride Tablets 325 mg/ 37.5 mg Ultracet Acyclovir Sodium1 Injection 50 mg/mL, 10 mL and 20 mL vials Zovirax Albuterol Sulfate Oral Syrup 2 mg(base)/ 5 mL Ventolin Albuterol...
Prescription and Over-the-Counter Drug Product List: 12/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL BUTALBITAL, ACETAMINOPHEN AND CAFFEINE >A> + MIKART 750MG;50MG;40MG N40496 001 DEC 23, 2003 DEC NEWA ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE TABLET; ORAL DARVOCET A500 >D> + AAIPHARMA 500MG;100MG N76429 001 SEP 10, 2003 DEC CTNA >A> + 500MG;100MG N76429 001 SEP 10, 2003 DEC CTNA...
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...
NDA Approvals for Calendar Year 2003 NDA APPROVALS FOR CALENDAR YEAR 2003 Updated through December 31, 2003 NDA NUMBER DRUG NAME GENERIC NAME APPLICANT/ SPONSOR CHEMICAL TYPE THERAPEUTIC CLASS APPROVAL DATE - 21434 Xanax XR Alprazolam Pharmacia and Upjohn FR 3 S 17-Jan-03 21305 Sodium Iodide I-131 Sodium Iodide I-131 DraxImage 3,5 S 24-Jan-03 20414 Pyridostigmine Bromide Pyridostigmine Bromide US Army 3 P 05-Feb-03...
author: Susan Daugherty
Prescription and Over-the-Counter Drug Product List: 11/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST >A> ABARELIX >A> INJECTABLE; INTRAMUSCULAR >A> PLENAXIS >A> + PRAECIS 100MG/VIAL N21320 001 NOV 25, 2003 NOV NEWA ALBUTEROL SULFATE SOLUTION; INHALATION ALBUTEROL SULFATE >A> AN BREATH LTD EQ 0.083% BASE N76370 001 NOV 24, 2003 NOV NEWA BACLOFEN TABLET, ORALLY DISINTEGRATING; ORAL KEMSTRO >D> SCHWARZ PHARMA 10MG N21589 001 OCT 30...
Cancer.gov - Smoking Cessation and Continued Risk in Cancer Patients (PDQ®) The exact mechanism by which bupropion HCl enhances the ability of patients to abstain from smoking is unknown; however, it is presumed that this action is mediated by noradrenergic or dopaminergic mechanisms.[ 1 ] Bupropion HCl A- BrandA- Dose A- Side EffectsA- Warning/precaution A- Rx = prescription RxA- ZybanA- 150 mg/day X 3 days then increase to 300 mg/day X 7-12...
Cancer.gov - Prevention and Cessation of Cigarette Smoking: Control of Tobacco Use (PDQ®) Despite high rates of recidivism at 1 year, the positive effect of the intervention persisted (19.6%-23.1% for the bupropion groups compared to 12.4% for placebo).[ 17 ] In another controlled trial, 244 subjects received bupropion only, 244 subjects received a nicotine patch, 245 subjects received both, and 160 subjects received placebo.[ 18 ] Interventions lasted 8 to 9...
Prescription and Over-the-Counter Drug Product List: 10/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE SOLUTION; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN >A> AA VINTAGE PHARMS 500MG/15ML;7.5MG/15ML N40520 001 OCT 30, 2003 OCT NEWA TABLET; ORAL ANEXSIA >D> AA MALLINCKRODT 750MG;10MG N40468 001 OCT 31, 2002 OCT CTNA >A> AA 750MG;10MG N40468 001 OCT 31, 2002 OCT CTNA ALBUTEROL SULFATE TABLET...
Microsoft Word - 6k_all.doc FORM 6- K SECURITIES AND EXCHANGE COMMISSION Washington, D.Hydrochloride Tablets did not infringe a U.Hydrochloride, 7.
author: Administrator
Microsoft Word - 6k_all.doc page 17
author: Administrator
Prescription and Over-the-Counter Drug Product List: 8/2003 4 >D> AA + ORTHO MCNEIL PHARM 300MG;60MG N85055 004 AUG DISC >A> @ 300MG;60MG N85055 004 AUG DISC ACETAMINOPHEN; HYDROCODONE BITARTRATE SOLUTION; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN >A> AA + MALLINCKRODT 500MG/15ML;10MG/15ML N40508 001 AUG 29, 2003 AUG NEWA >D> MIKART 500MG/15ML;5MG/15ML N81226 001 OCT 27, 1992 AUG CTEC >A> AA 500MG/15ML;5MG/15ML N81226 001 OCT 27, 1992 AUG...
author: AUTHOR
http://www.fda.gov/cder/ogd/rld/RLD_LABELING_APPROVED_JAN_1999.HTML 20-869 001 Merck Res 4-Jan-1999 LESCOL Fluvastatin Sodium Capsule 20-261 019 Novartis Pharm 4-Jan-1999 CORDARONE Amiodarone Hydrochloride Tablets 200 mg 18-972 017 Wyeth Ayerst Labs 5-Jan-1999 LAMISIL Terbinafine HCl Tablets 20-539 003 Novartis Pharms 5-Jan-1999 LOESTRIN FE 1.5/30 Ethinyl Estradiol/Norethindrone Tablets 17-355 043 Parke Davis 8-Jan-1999 LOESTRIN FE 1/20 Ethinyl...
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...
Prescription and OTC Drug Product List 6/2002 PEDIATRIC -A- + AAIPHARMA 80MG/VIAL;0.02MG/VIAL;0.001MG/VIAL; 5MG/VIAL;0.01MG/VIAL;0.14MG/VIAL;17 MG/VIAL;0.2MG/VIAL;1MG/VIAL;1.4MG/V IAL;EQ 1.2MG BASE/VIAL;0.7MG/VIAL;7MG/VIAL N18920 001 SEP 21, 2000 JUL CAHN -D- + NEOSAN PHARMS 80MG/VIAL;0.02MG/VIAL;0.001MG/VIAL; 5MG/VIAL;0.01MG/VIAL;0.14MG/VIAL;17 MG/VIAL;0.2MG/VIAL;1MG/VIAL;1.4MG/V IAL;EQ 1.2MG BASE/VIAL;0.7MG/VIAL;7MG/VIAL...
9820747 CENTER FOR DRUG EVALUATION AND RESEARCH Approval Package for: Application Number: 18644/ S010/ S012/ S013 Trade Name: WELLBUTRIN TABLETS Generic Name: BUPROPION HYDROCHLORIDE Sponsor: GLAXO WELLCOME, INC Approval Date: 11/ 27/ 95 AND 10/ 31/ 96 Indication( s): TREATMENT OF DEPRESSION CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION: 18644/ S010/ S012/ S013...
author: 4
subject: 18644, S010, S012, S013
9820747 page 1
author: 4
subject: 18644, S010, S012, S013
Microsoft Word - 75932TAF.doc ANDA 75- 932 Eon Labs Manufacturing, IncBupropion Hydrochloride Extended- Release Tablets, 100 mg and 150 mg
author: staufferp
Microsoft Word - 75932TAF.doc page 1
author: staufferp
Prescription and OTC Drug Product List 11/1999 Prescription and Over-the-Counter Drug Product List - 19th Edition Cumulative Supplement Number 11: November 1999 [ Prescription - OTC ] - ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ALBUTEROL SULFATE BUPROPION HYDROCHLORIDE SOLUTION; INHALATION TABLET; ORAL ALBUTEROL SULFATE - ADD - BUPROPION HCL - ADD - AN MORTON GROVE EQ 0.083% BASE N75394 001 - ADD -...
FDA Drug Approvals List- January 1999 Drug Approvals for January 1999 Definitions and Notes January 1999 Original New Drug Applications Original Application #: 020781 Approval Date: 27-JAN-99 Trade Name: ZOFRAN ODT Chemical Type: Therapeutic Potential: Dosage Form: TABLET Applicant: GLAXO WELLCOME INC Active Ingredient(s): ONDANSETRON OTC/RX Status: RX Indication(s): For the prevention of chemotherapy and radiation...
DDPA November 1995 74-493 CAPTOPRIL PAR CAPTOPRIL 14-NOV-95 (TABLET) SPRING VALLEY, NY 12.5MG 10977 25MG 50MG 100MG (ANGIOTENSIN CONVERTING ENZYME INHIBITOR) ***LABELING SUPPLEMENTS TO ORIGINAL NDAs*** 19-543 ELOCON SCHERING MOMETASONE FUROATE 03-OCT-95 (OINTMENT) KENILWORTH, NJ 0.1% 07033 (LABELING REVISION -- INDICATIONS AND USAGE; PRECAUTIONS; ADVERSE REACTIONS; DOSAGE AND ADMINISTRATION) 19-625...
DDPA March 1996 20-193 ELMIRON BAKER NORTON PENTOSAN POLYSULFATE SODIUM 01-MAR-96 (CAPSULE) MIAMI, FL 100MG 33178 (ANTICOAGULANT) 20-486 VANCERIL DS SCHERING BECLOMETHASONE DIPROPIONATE 06-MAR-96 (AEROSOL, METERED) KENILWORTH, NJ 0.084MG/INH 07033 (CORTICOSTEROID) 20-397 ZANAFLEX ATHENA NEUROSCIENCES TIZANIDIN E HYDROCHLORIDE 11-MAR-96 (TABLET) S SAN FRANCISCO, CA EQ 4MG BASE 94080 (ALPHA-2...
