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 (OTC)...
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- @...
Desmopressin acetate for von Willebrand's disease - [Medication] - Quest Diagnostics Patient Health Library Desmopressin acetate for von Willebrand's disease Examples Brand Name Chemical Name Concentraid desmopressin acetate (DDAVP) How It Works Desmopressin increases the amount of clotting factor VIII, which helps blood to clot.Desmopressin is used for people with mild to moderate von Willebrand's disease.Desmopressin can also...
AR 2007 Lo Res.pdf page 69
Pages Additional Patent Challenges During fiscal 2003, we announced five additional patent challenges, including challenges for: Eli Lilly's Evista® product for the treatment and prevention of osteoporosis in postmenopausal women; Kos Pharmaceutical's Niaspan® 500 mg and 750 mg extended release tablets for cholesterol; Ferring's patent related to DDAVP® (Desmopressin ...
author: Lisa
Pages page 5
author: Lisa
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...
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...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt "DIHYDROERGOTAMINE MESYLATE MANUFACTURED IN INGELHEIM, GERMANY" 10247 17-May-93 DIOSYNTH BV "PANCURONIUM BROMIDE MANUFACTURED IN OSS, THE NETHERLANDS" 10253 12-May-93 NEULAND LABORATORIES LTD "ALBUTEROL BASE MANUFACTURED IN BONTHAPALLI VILLIAGE, JINNARAM MANDAL, ANDHRA PRADESH, INDIA" 10262 25-May-93 JETPHARMA SA "CONTRACT MICRONIZATION SERVICES LOCATED IN BALERNA, SWITZERLAND" 10264...
http://www.fda.gov/cder/dmf/text/4Q2003NEWTEXT.txt CHINA." 16810 II 20-Aug-2003 ALPHARMA APS "TOBRAMYCIN SULFATE, USP STERILE AS MANUFACTUREED IN COPENHAGE, DENMARK" 16812 II 28-Aug-2003 "CAMBRIDGE MAJOR LABORATORIES, INC." "FP-043 AS MANUFACTURED IN GERMANTOWN, WI." 16813 II 3-Sep-2003 UCB BIOPRODUCTS "DESMOPRESSIN (ACETATE) AS MANUFACTURED IN BRAINE-L'ALLEUD, BELGIUM." 16818 II 26-Aug-2003 KUMAR ORGANIC PRODUCTS LIMITED...
http://www.fda.gov/cder/dmf/xls/4Q2003NEWEXCEL.xls Arthur Shaw CDER User $ ($) $ ($) $ ($) $ ($) $ $ () $ - () - $ $ () $ - () - -- -- $ ($) $ ($) $ ($) $ ($) / / // -- - - : : :: : () () () () () - $ $ () $ - () - $ $ () $ - : :: : 4Q2003NEWEXCEL DMF # Type SUBMIT DATE HOLDER SUBJECT IV COGNIS DEUTSCHLAND GMBH CO KG MYRITOL(R) 318 PH AS MANUFACTURED IN DUESSELDORF, GERMANYDESMOPRESSIN (...
http://www.paddocklabs.com/images/PadSec7-1.pdf page 4
Prescription and Over-the-Counter Drug Product List: 6/2003 >D> AT ALLERGAN 1% N61187 001 JUN DISC >A> @ 1% N61187 001 JUN DISC >D> SOLUTION/DROPS; OPHTHALMIC >D> CHLOROPTIC >D> + ALLERGAN 0.5% N50091 001 JUN DISC >A> @ 0.5% N50091 001 JUN DISC >D> CHLOROQUINE HYDROCHLORIDE >D> INJECTABLE; INJECTION >D> ARALEN HCL >D> + SANOFI SYNTHELABO EQ 40MG BASE/ML N06002 002 JUN DISC >A> @ EQ 40MG BASE/ML N06002 002 JUN DISC CHLORPROMAZINE HYDROCHLORIDE...
author: AUTHOR
Prescription and Over-the-Counter Drug Product List: 5/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL BUTALBITAL, APAP, AND CAFFEINE -A- AB AXIOM PHARM 325MG;50MG;40MG N89536 001 FEB 16, 1988 MAY CAHN -D- AB HALSEY 325MG;50MG;40MG N89536 001 FEB 16, 1988 MAY CAHN ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -A- AA ABLE 500MG;7.5MG...
author: AUTHOR
ANDAs Approvals - August 2000 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Office Of Generic Drugs ANDAs Approvals August 2000 1
author: USERNAME
Desmopressin Acetate Nasal Solution, .01% Approval Package Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Desmopressin Acetate Nasal Solution,.01% Company:- Bausch & Lomb Pharmaceuticals Inc
author: USERNAME
Efficacy Supplements Approved in Calendar Year 1998 DESMOPRESSIN ACETATE RHONE POULENC RORER 19-955 26-Mar-97 25-Mar-98 SE1 12.0 Primary nocturnal enuresisACETATE WYETH AYERST LABS 20-527 09-Jan-97 09-Jan-98 SE2 12.0 Treatment of moderate to severe vasomotor symptoms associated with the menopause; treatment of vulvar and vaginal atrophy; prevention of osteoporosis
author: Brenda Harmon
1997 Abbreviated New Drug Applications (Generic Drugs) Generic Drug Approval Packages These drug approval packages, sorted by product trade name, are supplied by the CDER Freedom of Electronic Information Office
http://www.fda.gov/cder/ogd/rld/RLD_LABELING_%20APPROVED_AUG_1998.HTML Susp 12-813 S-043 Allergan 03-Aug-1998 PROVERA Medroxyprogesterone Acetate Tablets 11-839 S-068 Pharmacia And Upjohn 04-Aug-1998 OVCON-35 Ethinyl Estradiol/Norethindrone Tablets 18-127 S-033 Bristol-Myers Squibb 10-Aug-1998 OVCON-35 Ethinyl Estradiol/Norethindrone Tablets 17-716 S-045 Bristol-Myers Squibb 10-Aug-1998 OVCON-35 Ethinyl Estradiol/Norethindrone Tablets 17-756 S-045...
Prescription and OTC Drug Product List 9/2002 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST -A- ADEFOVIR DIPIVOXIL -A- TABLET; ORAL -A- HEPSERA -A- + GILEAD 10MG N21449 001 SEP 20, 2002 SEP NEWA ALBUTEROL SULFATE TABLET, EXTENDED RELEASE; ORAL -A- ALBUTEROL SULFATE -A- AB SIDMAK LABS EQ 4MG BASE N76130 002 SEP 26, 2002 SEP NEWA -A- AB EQ 8MG BASE N76130 003 SEP 26, 2002 SEP NEWA VOLMAX -D- BC + MURO EQ 4MG BASE N19604...
Prescription and OTC Drug Product List 5/2002 2 -D- + ROBINS AH 325MG;15MG N84444 001 MAY DISC -A- @ 325MG;15MG N84444 001 MAY DISC SOLUTION; ORAL ACETAMINOPHEN AND CODEINE PHOSPHATE -D- AA ALPHARMA 120MG/5ML;12MG/5ML N85861 001 MAY CRLD -A- AA + 120MG/5ML;12MG/5ML N85861 001 MAY CRLD TYLENOL W/ CODEINE -D- AA + JOHNSON RW 120MG/5ML;12MG/5ML N85057 001 MAY DISC -A- @ 120MG/5ML;12MG/5ML N85057 001 MAY DISC TABLET; ORAL...
FDA Drug Approvals List February 2000 - Drug Approvals for February 2000 Definitions and Notes Original New Drug Applications Original Application #: 021015 Approval Date: 28-FEB-00 Trade Name: ANDROGEL Chemical Type: 3 Therapeutic Potential: S Dosage Form: GEL Applicant: UNIMED PHARMACEUTICALS INC Active Ingredient(s): TESTOSTERONE OTC/RX Status: RX Indication(s): For replacement therapy in males for conditions...
Document Information Page page 1
author: FDA.CDER
Guideline on Validation of the Limulus Amebocyte Lysate Test As An End-Product Endotoxin Text for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices at 56- 57oC) 3.00 mL Antirabies Serum 3.00 mL Antitoxin (Gas Gangrene) 3.00 mL Antivenom 3.00 mL Apommorphine HCl Tablets for Injection 0.09 mg Arginine HCl Injection 500.00 mg Ascorbic Acid 4.20 mg Asparaginase for Injection 1000.00 Iu Atracurium Besylate 0.50 mg Atropine Sulfate 0.09 mg Aurothioglucose Suspension 0.70 mg Azathioprine Sodium for Injection 5.00 mg Azlocillin 75.00 mg...
author: FDA / CBER
subject: December 1987 Guideline
Guideline on Validation of the Limulus Amebocyte Lysate Test As An End-Product Endotoxin Text for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices page 5
author: FDA / CBER
subject: December 1987 Guideline
