Drug Approvals - D NDA 18-841/S012 & 16 1/25/02 2/4/02 2/4/02 Daypro (oxyprozin) Caplets, 600 mg--- Pharmacia Corporation- NDA 18-841/S-020 4/9/03 4/16/03 4/16/03 DDAVP (desmopressin acetate) Nasal Spray, Injection & Tablets, Rx Aventis Pharmaceuticals NDA 17-922/S31, 18-938/S19 & 19-955/S5 11/12/03 11/25/03 - - DDAVP (desmopressin acetate) Injection, 4 µg/mL Aventis Pharmaceutical Products NDA 18...
http://www.fda.gov/cder/orange/appendix_a.txt 45, DIHYDROERGOTAMINE MESYLATE DACARBAZINE, DACARBAZINE DALGAN, DEZOCINE DALMANE, FLURAZEPAM HYDROCHLORIDE DANAZOL, DANAZOL DANOCRINE, DANAZOL DANTRIUM, DANTROLENE SODIUM DAPSONE, DAPSONE DARANIDE, DICHLORPHENAMIDE DARAPRIM, PYRIMETHAMINE DARBID, ISOPROPAMIDE IODIDE DARICON, OXYPHENCYCLIMINE HYDROCHLORIDE DARVOCET A500, ACETAMINOPHEN DARVOCET, ACETAMINOPHEN DARVOCET-N 100,...
21-064_Definity.htm Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Definity (Perflutren Lipid Microsphere) Injectable Suspension Company:--Dupont Pharmaceuticals Company Application No.:--21-064 Approval Date:-7/31/2001 - Approval Letter(s) - Printed Labeling - Medical Review(s) - Part 1 - Part 2 - Part 3 - Chemistry Review(s) -...
author: Paul Stauffer
Reference Listed Drug Labeling Approved in June 2002 Food and Drug Administration • Center for Drug Evaluation and Research Office of Generic Drugs Search Reference Listed Drug Labeling and Efficacy Supplements Approved in July 2002 Click on appropriate hyperlink below to view available source document in PDF format Approval Date Product Name Source Documents Active Ingredient(s)/Dosage Form Document ID No
author: USERNAME
Reference Listed Drug Labeling Approved in February 2002 - VIRACEPT letter label nelfinavir mesylate tablet 20-779 S-038 - VIRACEPT letter label nelfinavir mesylate oral powder 20-778 S-017 - ZOLADEX 3-month letter label goserelin acetate implant 20-578 S-013 - ZOLADEX 3.6 mg letter label goserelin acetate implant 19-726 S-034 Feb 6 MIRADON letter label anisindione tablet 10-909 S-013 - BUSPAR letter label buspirone HCl tablet 18-731 S-046...
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 Aerolizer)...
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 July 2001 - Drug Approvals for July 2001 Definitions and Notes Original New Drug Applications Original Application #: 021064 Approval Date: 31-JUL-01 Trade Name: DEFINITY Chemical Type: 1 Therapeutic Potential: S Dosage Form: INJECTION Applicant: DUPONT PHARMACEUTICALS CO Active Ingredient(s): PERFLUTREN LI MICROSPHERE OTC/RX Status: RX Indication(s): For the treatment patients...
FDA Drug Approvals List July 2002 PEDIATRIC Dosage Form: INJECTABLE Applicant: NEOSAN PHARMACEUTICALS Active Ingredient(s): ASCORBIC ACID; VITAMIN A; ERGOCALCIFEROL; THIAMINE HYDROCHLORIDE; RIBOFLAVIN PHOSPHATE SODIUM; PYRIDOXINE HYDROCHLORIDE; DEXPANTHENOL; VITAMIN E; BIOTIN; FOLIC ACID; CYANOCOBALAMIN; PHYTONADIONE; NIACINAMIDE OTC/RX Status: RX Application #: 018154 Labeling Supplement #: 023 To Original New Drug...
Prescription and OTC Drug Product List 7/2001 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL BUTALBITAL, ACETAMINOPHEN AND CAFFEINE -A- AB ABLE 325MG;50MG;40MG N40390 001 JUL 23, 2001 JUL NEWA -A- AB 500MG;50MG;40MG N40394 001 JUL 23, 2001 JUL NEWA ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -D- AA + WATSON LABS 325MG;7.5MG...
C:\DEFINITY\REV CYCLE 3\ACTION LETTER\AP ACTION LTR LAB 073101.doc NDA 21- 064 Page 4 4 DEFINITY ™ Vial for (Perflutren Lipid Microsphere) Injectable Suspension For Intravenous Use DESCRIPTION The DEFINITY ™ vial contains components that upon activation yield perflutren lipid microspheres, a diagnostic drug that is intended to be used for contrast enhancement during the indicated echocardiographic procedures
author: Thuy Nguyen
C:\DEFINITY\REV CYCLE 3\ACTION LETTER\AP ACTION LTR LAB 073101.doc page 7
author: Thuy Nguyen
C:\DEFINITY\REV CYCLE 3\ACTION LETTER\AP ACTION LTR LAB 073101.doc page 3
author: Thuy Nguyen
C:\DEFINITY\REV CYCLE 3\ACTION LETTER\AP ACTION LTR LAB 073101.doc page 2
author: Thuy Nguyen
C:\DEFINITY\REV CYCLE 3\ACTION LETTER\AP ACTION LTR LAB 073101.doc page 1
author: Thuy Nguyen
N:\NGUYEN\NDA 21064\LETTERS\AP 021402 SLR002 PA 070202.doc page 1
author: Thuy Nguyen
C:\NDA 21-064 Definity\Letters\1-30-03 AP for SCM-004.doc page 1
author: Lynn Panholzer
Definity Consumer Information Definity® Brand Name: Definity® Active Ingredient: - perflutren lipid microspheres- Dosage Form(s): - Intravenous injectable suspension- Company Name: -- DuPont Pharmaceuticals Availability: ------- Prescription only, professional use only *Date Approved by the FDA: - July 31, 2001 *Approval by FDA does not mean that the drug is available for consumers at this time
02-002 PhRMA NDA 2001 1/24 Osinski (Organon), (973) 325- 4805; Leslie Hare (Sanofi- Synthelabo), (212) 551- 4314 Axertª Pharmacia acute treatment of 12/ 20/ 99 5/ 7/ 01 16.6 months 2000 Spain almotriptan Peapack, NJ migraine with or malate tablets without aura in (S) adults For more information contact: Rose Talarico, (908) 901- 8516 Bextra ® Pharmacia treatment of signs and 1/ 16/ 01 11/ 16/ 01 10.0...
author: RL
02-002 PhRMA NDA 2001 1/24 page 11
author: RL
FY 2001 USER FEE NME APPROVALS - FY 2001 USER FEE NME APPROVALS AS OF SEPTEMBER 30, 2001 NDA# Trade Name (Generic Name) Dosage Form Applicant Date of Approval Class Indications(s) - 20-873 Angiomax- (bivalirudin) Injection The Medicines Company 15-Dec-00 - 1S Angiomax is used as an anticoagulant in conjunction with aspirin in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty ...
author: Brenda Harmon
Amersham plc: Annual Report & Accounts 2002 - Business at a glance: Amersham Health var pageLocation = document.URL var pageTitle = document.title separate = pageLocation.split("p-") PageNumbers = separate[1].split(".") page = PageNumbers[0] pagePrevious = page - 1 pageNext = pagePrevious + 2 function previous() { document.location = "rep-"+pagePrevious+".html" } function next() { document.location = "rep-"+pageNext+".html" } //for de-bugging //document.write("page...
Office of Drug Safety Annual Report 2001 Food and Drug Administration • Center for Drug Evaluation and Research Office of Drug Safety Search Office of Drug Safety Annual Report Center for Drug Evaluation and Research Food and Drug Administration Annual Report FY 2001 EXECUTIVE SUMMARY INTRODUCTION I
author: Honig P
Office of Drug Safety Annual Report 2001 Food and Drug Administration • Center for Drug Evaluation and Research Office of Drug Safety Search Office of Drug Safety Annual Report Center for Drug Evaluation and Research Food and Drug Administration Annual Report FY 2001 EXECUTIVE SUMMARY INTRODUCTION I
author: Honig P
http://www.yamanouchi.com/eg/ir/fi/fi0307/c.pdf / Generic name Therapeutic Target Classification Dosage Form In- house/ Alliance YM617 (tamsulosin) Lower urinary tract syndromes Alpha- 1 receptor antagonist Oral In- house YM086 (telmisartan) Diabetic nephropathy Angiotensin II receptor antagonist Oral Boehringer Ingerheim YM529 (minodronate) Bone metastasis with breast cancer Bisphosphonate Injection In- house YM866 (pamiteplase)...
