Generic Names of Some Trade Name Drugs, 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 - APPENDIX I - Drug Names: Generic and Trade TOPICS - Introduction -~ Some Trade Names of Generic Drugs -~ Generic Names of Some Trade Name Drugs - Generic Names of Some...
Some Trade Names of Generic Drugs, 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 - APPENDIX I - Drug Names: Generic and Trade TOPICS - Introduction -~ Some Trade Names of Generic Drugs-~ Generic Names of Some Trade Name Drugs - Some Trade Names of...
Valproic acid for epilepsy - [Medication] - Quest Diagnostics Patient Health Library Valproic acid for epilepsy Examples Brand Name Chemical Name Depakene valproic acid Depakote, Depakote ER divalproex sodium Depacon valproate sodium These medications usually require several doses each day.
Mood-stabilizing medications for bipolar disorder - [Medication] - Quest Diagnostics Patient Health Library Topic Contents - Examples - How It Works - Why It Is Used - How Well It Works - Side Effects - What To Think About - References Mood-stabilizing medications for bipolar disorder - [Medication] - Quest Diagnostics Patient Health Library Mood-stabilizing medications for bipolar disorder - [Medication] - Quest Diagnostics Patient Health Library bipolar disease, Bipolar disorder,...
Drug Approvals - D Product Name Company Application # Approval Date Letter Posted Label Posted Review Posted DMSA (Kit for the preparation of Tc99m Succimer for Injection), Rx Amersham Health NDA 17-944/S-018 11/24/03 11/25/03 - - Dacarbazine for Injection USP, 200 mg/vial, Rx Faulding Pharmaceutical CoDepacon (Valproate Sodium) Injection,...
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,...
Patent and Exclusivity Terms TREATMENT UP TO 6 MONTHS WAS SHOWN EFFICACIOUS D-55 ADDITION OF A HIGHER DOSE OF NUTROPIN FOR PUBERTAL PATIENTS (PUBERTAL DOSE LESS THAN OR EQUAL TO 0.7MG/KG/WEEK) D-56 ADDITION OF POSTPRANDIAL DOSING D-57 3-HOUR INFUSION OF TAXOL GIVEN EVERY THREE WEEKS AT A DOSE OF 175MG/M2 FOLLOWED BY CISPLATIN AT A DOSE OF 75MG/M2 FOR THE FIRST-LINE TREATMENT OF ADVANCED OVARIAN CANCER D-58...
1998 Warning Letters and Untitled Letters to Pharmaceutical Companies Searle DDMAC 5/26 8/3 Keri Anti-Bacterial Hand Lotion Bristol-Myers Squibb DLNDC 5/6 6/5 Naproxen Delayed Release Tablets Bristol-Myers Squibb DDMAC 5/26 8/3 Nasacort (Triamcinolone Acetonide) Rhone-Poulenc Rorer DDMAC 5/7 5/29 Pacerone (Amiodarone HCl) Tablets Upsher-Smith DDMAC 5/28 6/5 Pravachol (pravastatin sodium) Tablets Bristol-Myers Squibb DDMAC 5/1 6/16 Premarin (Conjugated...
First-Time Generics - November 2002 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search First-Time Generics - November 2002 - Generic Drug Name Generic Manufacturer Brand Name Product Approval Date 1 OMEPRAZOLE DELAYED-RELEASE CAPSULES 10 MG, AND 20 MG KREMERS URBAN DEVELOPMENT COMPANY PRILOSEC DELAYED-RELEASE CAPSULES 11/1/02 2 AMCINONIDE LOTION 0.1% ALTANA INC
author: OGD
Prescription and OTC Drug Product List 11/2002 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -A- AA ABLE 325MG;5MG N40478 001 NOV 08, 2002 NOV NEWA -A- AA 500MG;10MG N40473 001 NOV 06, 2002 NOV NEWA -A- AA 500MG;5MG N40477 001 NOV 06, 2002 NOV NEWA AMCINONIDE LOTION; TOPICAL -A- AMCINONIDE -A- AB ALTANA 0.1% N76329 001 NOV 06, 2002 NOV NEWA CYCLOCORT -D- + FUJISAWA...
Efficacy Supplements Approved in Calendar Year 2002 (SE1-SE7 AND SE8s EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR 2002 (SE1 -SE7)* and EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR 2002 (SE8)* - GENERIC NAME APPLICANT NDA NUMBER SUPP TYPE SUPP NUMBER RECEIPT DATE APPROVAL DATE PRIORITY REVIEW- TOTAL APPROVAL TIME (MONTHS) INDICATION/DESCRIPTION ANASTROZOLE ASTRAZENECA 20-541 SE1 010 5-Mar-02 5-Sep-02 Y 6.0 Provides for the use of ARIMIDEX ...
author: Darlene Norris
http://www.fda.gov/cder/foi/label/2002/20593se2006lbl.pdf 15 4) DEPACON VALPROATE ODIUM INJECTION Rx only BOX WARNING: HEPATOTOX C TY: HEPATIC FAILURE RESULTING IN FATALITIES HAS OCCURRED IN PATIENTS RECEIVING VALPROIC ACID AND ITS DERIVATIVESDEPACON IS USED IN THIS PATIENT GROUP, IT SHOULD BE USED WITH EXTREME CAUTION AND AS A SOLE AGENTVALPROATE CAN PRODUCE TERATOGENIC EFFECTS SUCH AS...
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http://www.fda.gov/cder/foi/label/2002/20593se2006lbl.pdf page 1
Information Page 1564) DEPACON O O VALPROATE SODIUM INJECTION Rx only BOX WARNING: HEPATOTOXICITY: HEPATIC FAILURE RESULTING IN FATALITIES HAS OCCURRED IN PATIENTS RECEIVING VALPROIC ACID AND ITS DERIVATIVESDEPACON are...
author: Jackie Ware
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author: Jackie Ware
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author: Jackie Ware
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author: Jackie Ware
FDA Drug Approvals List June 2000 Active Ingredient(s): MIDAZOLAM HYDROCHLORIDE OTC/RX Status: RX Original Abbreviated Application # 075448 Approval Date: 19-JUN-00 Trade Name: ISOSORBIDE MONONITRATE Dosage Form: TABLET, EXTENDED RELEASE Applicant: ZENITH GOLDLINE PHARMACEUTICALS Active Ingredient(s): ISOSORBIDE MONONITRATE OTC/RX Status: RX Original Abbreviated Application # 075549 Approval Date: 13-JUN-00 Trade...
http://www.fda.gov/cder/ogd/rld/18723s28.PDF Steck: Please refer to the following supplemental new drug applications submitted under section 505( b) of the Federal Food, Drug, and Cosmetic Act for Depakote Tablets (divalproex sodium delayed release tablets), Depakote Sprinkle Capsules (divalproex sodium coated particles in capsules), Depacon Injection (valproate sodium injection), Depakene Capsules (valproic acid capsules...
http://www.fda.gov/cder/ogd/rld/18082s23.PDF Steck: Please refer to the following supplemental new drug applications submitted under section 505( b) of the Federal Food, Drug, and Cosmetic Act for Depakote Tablets (divalproex sodium delayed release tablets), Depakote Sprinkle Capsules (divalproex sodium coated particles in capsules), Depacon Injection (valproate sodium injection), Depakene Capsules (valproic acid capsules...
DDPA June 1996 50-719 HELIDAC KIT PROCTOR GAMBLE PHARM BISMUTH SUBSALICYLATE 05-JUN-96 (TABLET, CHEWABLE; CINCINNATI, OH 262.4MG/TABLET CHEWABLE TABLET; 45241 METRONIDAZOLE CAPSULE) 250MG/TABLET TETRACYCLINE 500MG/CAPSULE (ANTIULCER) 20-593 DEPACON ABBOTT VALPROATE SODIUM 06-JUN-96 (INJECTABLE) ABBOTT PARK, IL EQ 100MG ACID/ML 60064 (ANTICONVULSANT) 20-441 PULMICORT-200 ASTRA BUDESONIDE...
