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 FLUORIDE...
Crohn's Disease: Inflammatory Bowel Diseases: Merck Manual Home Edition Search Recent Searches Index Sections 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 Accidents and Injuries Blood Disorders Bone, Joint, and Muscle Disorders Brain, Spinal Cord, and Nerve Disorders Cancer Children's Health Issues Digestive Disorders Disorders of Nutrition and Metabolism Drugs Ear, Nose, and Throat Disorders Eye Disorders Fundamentals Heart and Blood Vessel...
Aminosalicylates for inflammatory bowel disease - [Medication] - Quest Diagnostics Patient Health Library Balsalazide is used to treat mild to moderate ulcerative colitis.Balsalazide The most common side effects are headaches and abdominal pain.
20-610_Colazal_ Food and Drug Administration • Center for Drug Evaluation and Research Title Search Colazal (Balsalazide Disodium) Capsules Company:--Salix Pharmaceuticals, Inc
author: USERNAME
Report to the Nation: Drug Review Priority new drug approvals (N=NME) Abacavir/lamivudine/zidovudine (Trizivir) Alosetron (Lotronex) (N) Arsenic trioxide (Trisenox) (N) Atovaquone/proquanil (Malarone) Bexarotene (Targetin) Budesonide (Pulmicort) Didanosine (Videx EC) Gentuzumab ozogamicin (Mylotarg) (N) Levobetaxolol (Betaxon) Levofloxacin (Quixin) Linezolid (Zyvox) (3 NDAs approved, 1 as NME) (N) Lopinavir/ritonavir...
author: OLIVERN
NMEs Approved in CY 2000 NMEs Approved in Calendar Year 2000 NDA Number Generic Name- Trade Name Dosage Form Applicant - --- Classification- Approval Date 20-989 Cevimeline HCl Evoxac Capsule Snowbrand 1S 01-11-2000 21-014 Oxcarbazepine Trileptal Tablet Novartis Pharms 1S 01-14-2000 20-987 Pantoprazole Sodium Protonix Tablet Wyeth Ayerst 1S 02-02-2000 21-107 Alosetron HC1 Lotronex Tablet Glaxo Wellcome 1P 02...
author: Susan Daugherty
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 July 2000 - Drug Approvals for July 2000 Definitions and Notes Original New Drug Applications Original Application #: 050779 Approval Date: 27-JUL-00 Trade Name: CEFAZOLIN AND DEXTROSE Chemical Type: 5 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: B BRAUN MEDICAL INC Active Ingredient(s): CEFAZOLIN SODIUM OTC/RX Status: RX Indication(s): For the treatment of respiratory tract...
COLAZAL? (balsalazide disodium) Capsules Balsalazide disodium has the chemical name (E)- 5-[[- 4-[[( 2- carboxyethyl) amino] carbonyl] phenyl] azo]- 2- hydroxybenzoic acid, disodium salt, dihydrateBalsalazide disodium is a stable, odorless orange to yellow microcrystalline powder
author: Melodi McNeil
COLAZAL? (balsalazide disodium) Capsules page 2
author: Melodi McNeil
COLAZAL? (balsalazide disodium) Capsules page 1
author: Melodi McNeil
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt "SOTALOL HCL, MANUFACTURED IN MILANO, ITALY" 12274 13-Dec-96 SANKYO CO LTD "CS-834 DRUG SUBSTANCE, MANUFACTURED IN KANAGAWA, JAPAN" 12276 13-Dec-96 SANKYO CO LTD "CS-834 DRUG PRODUCT, MANUFACTURED IN TOKYO, JAPAN" 12277 16-Dec-96 PHARMA WALDHOF GMBH AND CO "5-BROMO-2'-DEOXYURIDINE, MANUFACTURED IN MANNHEIM, GERMANY" 12279 12-Dec-96 UNION QUIMICO FARMACEUTICA SA "PENTAACETYLIOPAMIDOL,...
http://www.phrma.org/newmedicines/resources/2001-01-10.11.pdf Angiomax The Medicines anticoagulant for patients 12/ 23/ 97 12/ 15/ 00 35.8 months 2000 New bivalirudin Company with unstable angina Zealand (S) Cambridge, MA undergoing percutaneous transluminal coronary angiopasity (PTCA) For more information contact: Sonja Loar, (617) 225- 9099 Argatroban GlaxoSmithKline prophylaxis or treatment 8/ 15/ 97 6/ 30/ 00 34.5 months 1989 Japan...
00-354 2000 PhRMA NDA 01/17 I n 2000, pharmaceutical and biotechnology companies received approval for 27 new drugs and 6 new biologicsdies as a result of blood and oxygen deprivation
author: RL
