http://www.fda.gov/cder/orange/appendix_a.txt 4, ACETAMINOPHEN PHENAPHEN-650 W/ CODEINE, ACETAMINOPHEN PHENAZINE, PHENDIMETRAZINE TARTRATE PHENAZINE-35, PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATE PHENERGAN FORTIS, PROMETHAZINE HYDROCHLORIDE PHENERGAN PLAIN, PROMETHAZINE HYDROCHLORIDE PHENERGAN VC W/ CODEINE, CODEINE PHOSPHATE PHENERGAN VC, PHENYLEPHRINE HYDROCHLORIDE PHENERGAN W/ CODEINE, CODEINE...
NDAs Approved under Subpart H NDAs Approved under Subpart H NDA # Trade Name Generic -Name Clock Date Approval Date AP Time Approval Basis Indication - - - - - - - - 20199 Hivid Zalcitabine 31-Oct-91 19-Jun-92 7.6 S Combination therapy with zidovudine in advanced HIV infection - - - - - - - - 50698 Biaxin Clarithromycin- 2-Nov-92 23-Dec-93 13.7 S Treatment of disseminated mycobacterial infections due to...
author: Darlene Norris
RLD_LABELING_ APPROVED_AUG_1999 Product Name Drug Name NDA No Supp.No Firm Date LARIAM Mefloquine HCl Tablets 19-591 S-012 Roche 02-Aug-1999 PROSCAR Finasteride Tablets 20-180 S-018 Merck 02-Aug-1999 CEFOTAN Cefatetan Disodium 50-588 S-026 Zeneca 05-Aug-1999 MARINOL Dronabinol Capsules 18-651 S-011 Unimed 05-Aug-1999 ZOCOR Simvastatin Tablets 19-766 S-032 Merck 05-Aug-1999 GLUCOTROL Glipizide Tablets 17-783 S-015...
Prescription and OTC Drug Product List 8/2001 ACTHAR GEL -D- BC + AVENTIS 40 UNITS/ML N08372 006 FEB 06, 1956 AUG CAHN -D- BC + 80 UNITS/ML N08372 008 FEB 06, 1956 AUG CAHN -A- BC + QUESTCOR PHARMS 40 UNITS/ML N08372 006 FEB 06, 1956 AUG CAHN -A- BC + 80 UNITS/ML N08372 008 FEB 06, 1956 AUG CAHN DELAVIRDINE MESYLATE TABLET; ORAL RESCRIPTOR -D- + AGOURON 100MG N20705 001 APR 04, 1997 AUG CRLD -A- 100MG N20705...
Efficacy Supplements Approved in Calendar Year 2001 (SE1-SE7 AND SE8S) EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR 2001 (SE1 -SE7)* and EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR 2001 (SE8)* - GENERIC NAME APPLICANT NDA NUMBER RECEIPT DATE APPROVAL DATE SUPP TYPE SUPP NUMBER PRIORITY REVIEW- TOTAL APPROVAL TIME (MONTHS) INDICATION/DESCRIPTION 13 C-UREA MERETEK 20-586 10-Jul-00 10-May-01 SE2 004 N 10.0 Provides for a decrease in dose of 13 C-urea...
author: Darlene Norris
Drug Approvals for April 1997 Drug Approvals for April 1997 Definitions and Notes April 1997 Original New Drug Applications Original Application #: 020619 Approval Date: 17-APR-97 Trade Name: BETOPTIC PILO Chemical Type: 4 Therapeutic Potential: S Dosage Form: SUSPENSION/DROPS Applicant: ALCON LABORATORIES INC Active Ingredient(s): BETAXOLOL HYDROCHLORIDE; PILOCARPINE HYDROCHLORIDE OTC/RX Status: RX Indication(s)...
FDA Drug Approvals List- February 1998 Drug Approvals for February 1998 Definitions and Notes February 1998 Original New Drug Applications Original Application #: 050750 Approval Date: 24-FEB-98 Trade Name: ZOSYN Chemical Type: 3 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: LEDERLE PIPERACILLIN INC DIV AMERICAN CYANAMID CO Active Ingredient(s): PIPERACILLIN SODIUM; TAZOBACTAM SODIUM OTC/RX Status: RX...
FDA Drug Approvals List August 1999 Approvable Original New Drug Applications Original Application #: 021037 Approvable Date: 26-AUG-99 Trade Name: MAGNEVIST Dosage Form: INJECTABLE Applicant: BERLEX LABORATORIES INC Active Ingredient(s): GADOPENTETATE DIMEGLUMINE OTC/RX Status: RX Original Application #: 020989 Approvable Date: 27-AUG-99 Trade Name: EVOXAC Dosage Form: CAPSULE Applicant: SNOWBRAND PHARMACEUTICALS INC...
THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs, QUARZAN to SYPRINE Trade Names of Some Commonly Used Drugs TRADE AND GENERIC NAMES OF COMMONLY USED DRUGS QUARZAN to SYPRINE Trade Name Generic QUARZAN *Clidinium QUESTRAN Cholestyramine QUINAGLUTE Quinidine RAXAR Grepafloxacin REBETRON Ribavirin RECOMBIVAX HB Hepatitis B vaccine REGITINE Phentolamine REGLAN Metoclopramide RELAFEN Nabumetone RELENZA Zanamivir REOPRO Abciximab REQUIP Ropinirole ...
THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs, Dacarbazine to Etretinate Trade Names of Some Commonly Used Drugs GENERIC AND TRADE NAMES OF COMMONLY USED DRUGS Dacarbazine to Etretinate Generic Trade Name Dacarbazine DTIC-DOME Dactinomycin COSMEGEN Danazol DANOCRINE Dantrolene DANTRIUM Daunorubicin CERUBIDINE Deferoxamine DESFERAL Delavirdine RESCRIPTOR Demeclocycline DECLOMYCIN Desipramine NORPRAMIN, PERTOFRANE Desmopressin DDAVP, STIMATE...
Patient Information Drug Information Sheet for Patients Antiretroviral Drug Classes Nucleoside Analogue Reverse Transcriptase Inhibitors 2,3-Dideoxycytidine (ddC, Hivid®) Abacavir (1592U89, Ziagen®) Abacavir (Ziagen) Hypersensitivity Reaction -- Didanosine(DDI, VIDEX® chew tabs, VIDEX® EC) - Lamivudine (3TC, Epivir®) (Combivir® - with AZT) Stavudine (d4T, Zerit®)...
HIV EMERGENCIES Caroline Kowal HIV EMERGENCIES Caroline Kowal _ _ HIV EMERGENCIES Caroline Kowal Objectives n Review HIV n Pulmonary Complications in ED Neurologic Complications in ED Severe Drug Reaction What’s new in post exposure prophylaxis
author: Caroline Kowal
THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs, QUARZAN to SYPRINE Trade Names of Some Commonly Used Drugs TRADE AND GENERIC NAMES OF COMMONLY USED DRUGS QUARZAN to SYPRINE Trade Name Generic QUARZAN *Clidinium QUESTRAN Cholestyramine QUINAGLUTE Quinidine RAXAR Grepafloxacin REBETRON Ribavirin RECOMBIVAX HB Hepatitis B vaccine REGITINE Phentolamine REGLAN Metoclopramide RELAFEN Nabumetone RELENZA Zanamivir REOPRO Abciximab REQUIP Ropinirole ...
THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs, Dacarbazine to Etretinate Trade Names of Some Commonly Used Drugs GENERIC AND TRADE NAMES OF COMMONLY USED DRUGS Dacarbazine to Etretinate Generic Trade Name Dacarbazine DTIC-DOME Dactinomycin COSMEGEN Danazol DANOCRINE Dantrolene DANTRIUM Daunorubicin CERUBIDINE Deferoxamine DESFERAL Delavirdine RESCRIPTOR Demeclocycline DECLOMYCIN Desipramine NORPRAMIN, PERTOFRANE Desmopressin DDAVP, STIMATE...
HIV GenoSure Report--11-25-03.ai ©2003 Laboratory Corporation of America ® Holdings All Rights Reserved L890- 1103- 5 6170574201 1912 Alexander Drive Research Triangle Park NC, 27709 (800) 533- 0567 GENOTYPING REPORT Patient Information Routing Information Account Information / Age: Months Years Birth Date: Sex: SSN: Patient ID: SAMPLE, TEST Name / Initials: Visit: 10/ 31/ 2003 Reported: 10/ 23/ 2003...
author: harrelc
Delavirdine; Rescriptor® ; BHAP der.; U90152S Delavirdine; Rescriptor ® ; BHAP der.; U90152S In-vitro Data Cell Strain EC50 IC50 Units TI Reference PBMC HIV-1(IIIB) 0.0001 -10 µM -100,000 1 MT-2 HIV-1(D34) 0.01 -30 µM -3000 1 MT-4 HIV-1(IIIB) EC90=0.05 - µM - 2 MT-4 HIV-1(MF (RT-P236L))* EC90=-10 - µM - 2 MT-4 HIV-1(IIIB (RT-L100I, M230L ))* EC90=-10 - µM - 2 MT-4 HIV-1(IIIB (RT-Y181C ))^...
Drug Index ; Rescriptor ® ; Delavirdine; U-90152 BHAP deriv
Drug Index ; Rescriptor ® ; Delavirdine; U-90152 BHAP deriv
CRIXIVAN Clinically significant interactions were observed with the following drugs: Delavirdine Due to an increase in indinavir plasma concentrations (preliminary results), a dosage reduction of indinavir should be considered when CRIXIVAN ® and delavirdine are coadministered (see DOSAGE AND ADMINISTRATION, Concomitant Therapy, Delavirdine, PHARMACOLOGY, Drug Interactions, ...
author: Merck Frosst Canada & Co
subject: 777-a,7,02
Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) ANTIRETROVIRAL AGENTS used for the treatment of pediatric HIV infection 1,2 a worksheet summarized for the healthcare professional NON-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) ; MOA – these agents bind to REVERSE TRANSCRIPTASE , which blocks further construction of the virus; common toxicity include a high incidence of rash
V:\DAVDP\CSO\BELOUIN\GoldNda s\20705\Traditional Approval Action Package\ApprovalLetter.doc NDA 20- 705/ S- 008 Page 3 If a letter communicating important information about this drug product (i
author: Sean Belouin
duplicates:http://www.fda.gov/cder/foi/label/2001/20705S8lbl.pdf
V:\DAVDP\CSO\BELOUIN\GoldNda s\20705\Traditional Approval Action Package\ApprovalLetter.doc page 3
author: Sean Belouin
duplicates:http://www.fda.gov/cder/foi/label/2001/20705S8lbl.pdf
V:\DAVDP\CSO\BELOUIN\GoldNda s\20705\Traditional Approval Action Package\ApprovalLetter.doc page 2
author: Sean Belouin
duplicates:http://www.fda.gov/cder/foi/label/2001/20705S8lbl.pdf
Virco Drugs and Resistance - Despite the availability of up to 16 drugs to fight HIV infections, many treatments fail in the long run. Resistance to these drugs is one of the leading causes of treatment failure. ...
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