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Nucleoside reverse transcriptase inhibitors (NRTIs) for HIV - [Medication] - Quest Diagnostics Patient Health Library
Nucleoside reverse transcriptase inhibitors (NRTIs) for HIV Examples Brand Name Chemical Name Ziagen abacavir Videx didanosine, also known as dideoxyinosine, ddI 3TC, Epivir lamivudine Zerit stavudine (d4T) Hivid zalcitabine, also known as dideoxycytidine, ddC Retrovir zidovudine (ZDV), formerly known as azidothymidine (AZT) Trizivir abacavir, zidovudine, and lamivudine ...
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http://www.fda.gov/cder/orange/appendix_a.txt
4, ACETAMINOPHEN TYLENOL W/ CODEINE, ACETAMINOPHEN TYLENOL, ACETAMINOPHEN (OTC) TYLOX, ACETAMINOPHEN TYLOX-325, ACETAMINOPHEN TYMTRAN, CERULETIDE DIETHYLAMINE TYZINE, TETRAHYDROZOLINE HYDROCHLORIDE TZ-3, TIOCONAZOLE (OTC) ** U ** U-CORT, HYDROCORTISONE ACETATE U-GENCIN, GENTAMICIN SULFATE UCEPHAN, SODIUM BENZOATE ULO, CHLOPHEDIANOL HYDROCHLORIDE ULTANE, SEVOFLURANE ULTIVA,...
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Trizivir
Trizivir ® ; Abacavir (sulfate) & Lamivudine & Zidovudine ; ABC & (-)-3TC & AZT Trizivir ® combines 300 mg of abacavir (as sulfate salt), 150 mg of lamivudine and 300 mg of zidovudine into a single tablet that is usually taken twice a day (1)
Trizivir ® tablets have been shown to be bioequivalent to abacavir, 3TC and AZT taken individually (2)...
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Drug Index
AA ; L-ascorbic acid; Calcium Ascorbate AAP-BHAP ; U-104489; PNU-104489 Abacavir Succinate ; 1592U89 Succinate; Ziagen® Approved Abacavir & Lamivudine & Zidovudine ; Trizivir® ABC & (-)-3TC & AZT ABT-378 ; Lopinavir; Component of Kaletra; Aluviran® ABT-378 & ABT-538 ; Kaletra ® ; Lopinavir & Ritonavir; Aluviran ® & Norvir ® ABT-538 ; Norvir...
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Drug Index
AA ; L-ascorbic acid; Calcium Ascorbate AAP-BHAP ; U-104489; PNU-104489 Abacavir Succinate ; 1592U89 Succinate; Ziagen® Approved Abacavir & Lamivudine & Zidovudine ; Trizivir® ABC & (-)-3TC & AZT ABT-378 ; Lopinavir; Component of Kaletra; Aluviran® ABT-378 & ABT-538 ; Kaletra ® ; Lopinavir & Ritonavir; Aluviran ® & Norvir ® ABT-538 ; Norvir...
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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
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FDA Drug Approvals List June 2002
- Drug Approvals for June 2002 Definitions and Notes Original New Drug Applications Original Application # 021316 Approval Date: 26-JUN-02 Trade Name: ALTOCOR Chemical Type: 3 Therapeutic Potential: S Dosage Form: TABLET Applicant: AURA LABORATORIES INC Active Ingredient(s): LOVASTATIN OTC/RX Status: RX INDICATION OF USE: For lowering total cholesterol and LDL-C to target levels as...
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Efficacy Supplements Approved in Calendar Year 2002 (SE1-SE7 AND SE8s
----------- This list is updated quarterly.- Updated through 12/31/02 -------------------- Top of Page ---------- EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR 2002 (SE8)* Top of Page GENERIC NAME APPLICANT NDA NUMBER SUPP TYPE SUPP NUMBER RECEIPT DATE APPROVAL DATE PRIORITY REVIEW TOTAL APPROVAL TIME (MONTHS) ABACAVIR SULFATE, LAMIVUDINE, AND ZIDOVUDINE...
author: Darlene Norris
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Research Studies
CNA30032 – Glaxo Wellcome - A Retrospective, Case-Control Study to Investigate Genetic Polymorphisms in Hiv Infected Subjects Who Developed Hypersensitivity Following treatment With Abacavir Enrollment Status: Complete Projected Enrollment: 15 APV30002 – Glaxo Wellcome – A Randomized, Open-Label, Two Arm Trial to Compare the Safety and Antiviral Efficacy of...
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V:\DAVDP\CSO\YOERG\NDA\Crimson\21-205triz\SLRs\slr007\approvall\ tr.doc
Drugs That May Alter Lamivudine Blood Concentrations Coadministered Lamivudine Lamivudine Concentrations Concentration of Coadministered Drug and Dose Dose n AUC Variability Drug Nelfinavir 750 mg q 8 hr x 7 to 10 days single 150 mg 11 10% 95% CI: 1% to 20% Trimethoprim 160 mg/ Sulfamethoxazole 800 mg daily x 5 days single 300 mg 14 43% 90% CI: 32% to 55% Drugs That...
author: Virginia Yoerg
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21-205 S-002 AP TRIZIVIR.pdf
Drugs That May Alter Lamivudine Blood Concentrations Coadministered Lamivudine Lamivudine Concentrations Concentration of Coadministere d Drug and Dose Dose n AUC Variability Drug Nelfinavir 750 mg q 8 h x 7 to 10 days single 150 mg 11 10% 95% CI: 1% to 20% Trimethoprim 160 mg/ Sulfamethoxazole 800 mg daily x 5 days single 300 mg 14 43% 90% CI: 32% to 55% Drugs That...
author: gracej
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21-205 S-002 AP TRIZIVIR.pdf page 2
author: gracej
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V:\DAVDP\CSO\YOERG\NDA\Crimson\21-205triz\SLRs\cbe003.004\apltr\ .doc
Drugs That May Alter Lamivudine Blood Concentrations Coadministered Lamivudine Lamivudine Concentrations Concentration of Coadministered Drug and Dose Dose n AUC Variability Drug Nelfinavir 750 mg q 8 h x 7 to 10 days single 150 mg 11 10% 95% CI: 1% to 20% Trimethoprim 160 mg/ Sulfamethoxazole 800 mg daily x 5 days single 300 mg 14 43% 90% CI: 32% to 55% Drugs That...
author: Virginia Yoerg
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V:\DAVDP\CSO\YOERG\NDA\Crimson\21-205triz\SLRs\slr006\approvall\ tr.doc
Drugs That May Alter Lamivudine Blood Concentrations Coadministered Lamivudine Lamivudine Concentrations Concentration of Coadministered Drug and Dose Dose n AUC Variability Drug Nelfinavir 750 mg q 8 h x 7 to 10 days single 150 mg 11 10% 95% CI: 1% to 20% Trimethoprim 160 mg/ Sulfamethoxazole 800 mg daily x 5 days single 300 mg 14 43% 90% CI: 32% to 55% Drugs That...
author: Virginia Yoerg
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V:\DAVDP\CSO\YOERG\NDA\Crimson\21-205triz\SLRs\slr006\approvall\ tr.doc page 2
author: Virginia Yoerg
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Prescription and OTC Drug Product List 12/1998
Prescription and Over-the-Counter Drug Product List - 18th Edition Cumulative Supplement Number 12: December 1998 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST - ADD - ABACAVIR SULFATE ALBUTEROL SULFATE - ADD - SOLUTION; ORAL SOLUTION; INHALATION - ADD - ZIAGEN ALBUTEROL SULFATE - ADD - + GLAXO WELLCOME EQ 20MG BASE/ML N20978...
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Prescription and OTC Drug Product List 11/2000
Prescription and Over-the-Counter Drug Product List - 20th Edition Cumulative Supplement Number 11: November 2000 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST - ADD - ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE AMOXICILLIN - ADD - TABLET; ORAL TABLET; ORAL - ADD - TRIZIVIR AMOXICILLIN - ADD - + GLAXO WELLCOME EQ 300MG BASE;150MG;300MG...
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FDA Drug Approvals List November 2000
- Drug Approvals for November 2000 Definitions and Notes Original New Drug Applications Original Application #: 050782 Approval Date: 27-NOV-00 Trade Name: TRADENAME Chemical Type: 3 Therapeutic Potential: S Dosage Form: GEL Applicant: TARGET RESEARCH ASSOCIATES Active Ingredient(s): CLINDAMYCIN PHOSPHATE OTC/RX Status: RX Indication(s): FOR ONCE A DAY TREATMENT OF ACNE VULGARIS...
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Cover 0519.qxd
This weeks UK Patents and Design Journal (PDJ) contained details of one SPC grant and notification of three SPCs entering into force.
It is marketed in Europe by Schering AG.
The settlement included a license by Ribapharm of ribavirin to Roche, who also have an approval to market ribavirin in combination with their Pegasys product.
On 29 th April, GlaxoSmithKline submitted...
author: GWhite
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Cover 0519.qxd page 1
author: GWhite
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