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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.
See Humira ™ (2913) D4E1 (Peptidyl MIM™) (1134) DAB389IL-2.
See DN1924 - (2900) DAPD (Amdoxovir) (1668).
Further product...
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Urinary Incontinence
Urinary Incontinence (Overactive Bladder Syndrome) Extra Large Market.- Growing Market Prospective Market.- There are approximately 200 million people world-wide suffering from urinary incontinence, with less than 20% of them undergoing some form of the treatment.
Urinary incontinence, or overactive bladder syndrome, afflicts more than 50 million people in the U.
S., Europe and...
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Cedra Corp. Methods List April 2004.xls
Humor 0.025 mL 1 250 ng/ mL Tizanidine Human Heparin Plasma 0.5 mL 0.1 – 50 ng/ mL Tolterodine Human Heparin Plasma 0.5 mL 0.5 – 50 ng/ mL Tramadol* and 5- 200 ng/ mL M1* 1- 40 ng/ mL Tramadol* and 1 250 ng/ mL M1* 0.5 125 ng/ mL 10- 400 ng/ mL 10- 400 ng/ mL Tramadol* and 10 – 1000 ng/ mL O- Desmethyltramadol* 10 – 1000 ng/ mL N- Desmethyltramadol* 10 –...
author: Information Systems
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Drug Approvals - D
ANDA 74-904 7/14/98 7/14/98 - 3/16/99 Desoxyn (methamphetamine HCl) Tablets and Desoxyn (methamphetamine HCl) Gradumet Tablets, 5 mg & 5 mg, 10 mg, and 15 mg, Rx- Abbott Laboratories NDA 5-378/S-020 12/6/01 4/3/03 Detrol LA Extended- Release Capsules, Rx Pharmacia and Upjohn NDA 21-228 /S5 1/15 /04 1/22/04 - Detrol LA Extended- Release Capsules, Rx Pharmacia and Upjohn NDA 21-228 /S4...
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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,...
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http://www.fda.gov/cder/dmf/text/4Q2003NEWTEXT.txt
"INJECTION BLOW MOLDED PLASTIC BOTTLES AS MANUFACTURED IN LJUBLJANA, SLOVENIA." 16995 II 3-Dec-2003 TEVA GROUP "TOLTERODINE TARTRATE AS MANUFACTURED IN BE'ER SHEVA, ISRAEL." 16996 II 3-Dec-2003 TEVA GROUP "LOSARTAN POTASSIUM AS MANUFACTURED IN BEER SHEVA, ISRAEL." 16997 II 30-Oct-2003 BACHEM AG "HISTRELIN ACETATE AS MANUFACTURED IN BUBENDORF, SWITZERLAND." 16998 II 1-Dec...
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Cedra Corp. Methods List January 2004.xls page 10
author: Information Systems
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Cedra Corp. Methods List January 2004.xls
Humor LC- MS- MS 0.1 250 ng/ mL Tizanidine Human Heparin Plasma LC- MS- MS 0.1 – 50 ng/ mL Tolterodine Human Heparin Plasma LC- MS- MS 0.5 – 50 ng/ mL Tramadol* and 5- 200 ng/ mL M1* 1- 40 ng/ mL Tramadol* and 1 250 ng/ mL M1* 0.5 125 ng/ mL 10- 400 ng/ mL 10- 400 ng/ mL Tramadol* and 10 – 1000 ng/ mL O- Desmethyltramadol* 10 – 1000 ng/ mL N-...
author: Information Systems
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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, GERMANY
II SLOVAKOFARMA AS ZOL EM TARTRATE AS MANUFACTURED...
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FDA Drug Approvals List September 2001
- Drug Approvals for September 2001 Definitions and Notes Original New Drug Applications Original Application #: 021279 Approval Date: 25-SEP-01 Trade Name: FORADIL Chemical Type: 3 Therapeutic Potential: S Dosage Form: POWDER, FOR INHALATION Applicant: NOVARTIS PHARMACEUTICALS CORP Active Ingredient(s): FORMOTEROL FUMARATE OTC/RX Status: RX Indication(s): For the long-term, twice...
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FDA Drug Approvals List April 2001
- Drug Approvals for April 2001 Definitions and Notes Original New Drug Applications Original Application #: 020949 Approval Date: 30-APR-01 Trade Name: ACCUNEB Chemical Type: 5 Therapeutic Potential: S Dosage Form: SOLUTION Applicant: DEY LABORATORIES INC Active Ingredient(s): ALBUTEROL SULFATE OTC/RX Status: RX Indication(s): For the treatment of asthma-related bronchospasm in...
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Efficacy Supplements Approved in Calendar Year 2001 (SE1-SE7 AND SE8S)
-------------------- Top of Page -------- Last Updated on 1/28/02 ---- --- By CDER.USER EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR 2001 (SE8)* Top of Page GENERIC NAME APPLICANT NDA NUMBER RECEIPT DATE APPROVAL DATE SUPP TYPE SUPP NUMBER PRIORITY REVIEW TOTAL APPROVAL TIME (MONTHS) ADENOSINE FUJISAWA HLTHCARE 20-059 11-Aug-99 31-Aug-01 SE8 007 N 24.7 ATORVASTATIN CALCIUM PFIZER...
author: Darlene Norris
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Prescription and OTC Drug Product List 12/2000
Prescription and Over-the-Counter Drug Product List - 20th Edition Cumulative Supplement Number 12: December 2000 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE - ADD - BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE TABLET; ORAL - ADD - GEL; TOPICAL OXYCODONE AND ACETAMINOPHEN - ADD - BENZACLIN - ADD - AA WATSON LABS...
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FDA Drug Approvals List- March 1998
Drug Approvals for March 1998 Definitions and Notes March 1998 Original New Drug Applications Original Application #: 020827 Approval Date: 30-MAR-98 Trade Name: MONISTAT 3 Chemical Type: 3 Therapeutic Potential: S Dosage Form: CREAM Applicant: ADVANCED CARE PRODUCTS Active Ingredient(s): MICONAZOLE NITRATE OTC/RX Status: OTC Indication(s): For the over-the-counter treatment of...
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FDA Drug Approvals List December 2000
- Drug Approvals for December 2000 Definitions and Notes Original New Drug Applications Original Application #: 021228 Approval Date: 22-DEC-00 Trade Name: DETROL LA Chemical Type: 3 Therapeutic Potential: S Dosage Form: CAPSULE Applicant: PHARMACIA AND UPJOHN CO Active Ingredient(s): TOLTERODINE TARTRATE OTC/RX Status: RX Indication(s): For the treatment of overactive...
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FDA Drug Approvals List October 2000
- Drug Approvals for October 2000 Definitions and Notes Original New Drug Applications Original Application #: 020958 Approval Date: 16-OCT-00 Trade Name: PEPCID COMPLETE Chemical Type: 4 Therapeutic Potential: S Dosage Form: TABLET, CHEWABLE Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC Active Ingredient(s): CALCIUM CARBONATE, PRECIPITATED; FAMOTIDINE; MAGNESIUM HYDROXIDE...
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Index T, THE MERCK MANUAL OF HEALTH & AGING
Committed to Providing Medical Information Table of Contents Index Enlarge Text Reset Text Shrink Text -- Buy the Book Learn about participating in clinical trials at this government website: www.clinicaltrials.gov - INDEX - Index-A -~ Index-B -~ Index-C -~ Index-D -~ Index-E -~ Index-F -~ Index-G -~ Index-H -~ Index-I -~ Index-J -~ Index-K -~ Index-L -~ Index-M -~ Index-N -~ Index-O...
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Index: TO: Merck Manual Home Edition
Morton's neuroma of Foot Pain: Pain Caused by Damage to the Nerves in the Foot Toenails thickening of (onychauxis and onychogryphosis) Onychauxis and Onychogryphosis Toilet teaching Toilet Teaching Tolazamide Oral Antihyperglycemic Drugs Tolbutamide Oral Antihyperglycemic Drugs during pregnancy Some Drugs That Can Cause Problems During Pregnancy Tolcapone Drugs Used to Treat...
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THE MERCK MANUAL OF GERIATRICS, Index T
- Index Index-A -| Index-B -| Index-C -| Index-D -| Index-E -| Index-F -| Index-G -| Index-H -| Index-I -| Index-J &n; bsp;| Index-K -| Index-L -| Index-M -| Index-N -| Index-O -| Index-P -| Index-Q -| Index-R -| Index-S -| Index-T -| Index-U -| Index-V -| Index-W -| Index-X,Y,Z Index T Tachycardia 885-895 , 886t , 888t atrial (supraventricular) 889-892 -----with block 889 ----...
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Contents Vol. 12, No. 2, 2004
2, 2004 Contents Current Opinion Impact of Guidelines on Healthcare from the Patient and Payor 73- 79 Perspective: Example of the American Pain Society Guidelines B McCarberg Review Article Impact of Three- Tier Pharmacy Benefit Structures on Consumer 81- 92 Attitudes, Pharmacy, Medical Utilization and Costs: A Critical Review KV Nair, RJ Valuck Original Research Article Improvements...
author: Adis International Limited
subject: Disease Management & Health Outcomes
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Contents Vol. 24, No. 6, 2004
6, 2004 Contents Original Research Cost Effectiveness of Controlled- Release Oxybutynin 305- 321 Articles Compared with Immediate- Release Oxybutynin and Tolterodine in the Treatment of Overactive Bladder in the UK, France and Austria JF Guest, D Abegunde, FJ Ruiz Lack of Interaction between Modified- Release Fluvastatin 323- 331 and Amlodipine in Healthy Subjects PP Prasad, D...
author: Adis International Limited
subject: Clinical Drug Investigation
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Cedra Corp. Methods List April 2004.xls page 10
author: Information Systems
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http://www.adis.com/files/newsletters/INP/Icov1430.pdf
6 Tamoxifen + sulindac for desmoid tumours 16 Trabectedin in advanced soft tissue sarcoma 8 NEUROLOGY Trastuzumab treats bone marrow metastases 18 Acetylcholinesterase inhibitors: new approach to design 4 Benzodiazepines in treatment of neonatal seizures 17 CARDIO/ VASCULAR Flupirtine slows cognitive decline in CJD 15 Amiodarone vs propafenone in recurrent AF 18 Galantamine shows...
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Contents Vol. 24, No. 2, 2004
2, 2004 Contents Original Research Effect of Various Antimicrobial Regimens on the Clinical 63- 72 Articles Course of Exacerbations of Chronic Bronchitis and Chronic Obstructive Pulmonary Disease in Primary Care M Miravitlles, C Llor, K Naberan, JM Cots, J Molina Safety and Tolerability of Volplex in Elective Surgery 73- 79 RJ Sneyd, BC Dean, C Dwyer Oxybutynin Extended Release and ...
author: Adis International Limited
subject: Clinical Drug Investigation
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Approved Active Moieties to Which FDA has Granted Pediatric Exclusivity for Pediatric Studies
Approved Active Moieties to Which FDA has Granted Pediatric Exclusivity for Pediatric Studies under Section 505A of the Federal Food, Drug, and Cosmetic Act NOTE: This list simply identifies approved active moieties with sponsors to which FDA has granted exclusivity for pediatric studies
Total Exclusivity Determinations = 104 Total Approved Active Moieties Granted Exclusivity = 88...
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