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,...
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)abacavir, 3TC and AZT taken individually (2)
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®;...
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®;...
20-977_Ziagen Food and Drug Administration • Center for Drug Evaluation and Research Title Search Ziagen (Abacavir Sulfate) Tablets & Oral Solution Company:--Glaxo Wellcome Inc
author: USERNAME
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
Fast Track Designated Products Approved since 1998 FAST TRACK DESIGNATED PRODUCTS APPROVED SINCE 1998 Through September 30, 2003 - NDA# NDA Drug Name Sponsor Applicant Approval Date Indication N020972 Sustiva (Efavirenz) 50/ 100/ 200MG Caps Dupont Pharms 9/17/98 Treatment of HIV N20977 Ziagen (Abacavir Sulfate) Tablets Glaxo Wellcome 12/17/98 Treatment of HIV N20978 Ziagen (Abacavir Sulfate) Oral Solution 12...
author: Michael Lanthier
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...
FDA Drug Approvals List April 2000 Approvable Original New Drug Applications Original Abbreviated New Drug Applications Original Abbreviated Application # 074657 Approval Date: 28-APR-00 Trade Name: TERAZOSIN HCL Dosage Form: TABLET Applicant: INVAMED INC Active Ingredient(s): TERAZOSIN HYDROCHLORIDE OTC/RX Status: RX Original Abbreviated Antibiotic Application# 065041 Approval Date: 28-APR-00 Trade Name: DOXYCYCLINE...
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 GLAXOSMITHKLINE...
author: Darlene Norris
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...
V:\DAVDP\CSO\YOERG\NDA\Crimson\21-205triz\SLRs\slr007\approvall\ tr.doc Abacavir Sulfate: The chemical name of abacavir sulfate is (1S, cis)- 4-[ 2- amino- 6- (cyclopropylamino)- 9H- purin- 9- yl]- 2- cyclopentene- 1- methanol sulfate (salt) (2: 1)
author: Virginia Yoerg
V:\DAVDP\CSO\YOERG\NDA\Crimson\21-205triz\SLRs\slr007\approvall\ tr.doc page 2
author: Virginia Yoerg
21-205 S-002 AP TRIZIVIR.pdf Abacavir Sulfate: The chemical name of abacavir sulfate is (1S, cis)- 4-[ 2- amino- 6- (cyclopropylamino)- 9H- purin- 9- yl]- 2- cyclopentene- 1- methanol sulfate (salt) (2: 1)
author: gracej
21-205 S-002 AP TRIZIVIR.pdf page 2
author: gracej
V:\DAVDP\CSO\YOERG\NDA\Crimson\21-205triz\SLRs\cbe003.004\apltr\ .doc Abacavir Sulfate: The chemical name of abacavir sulfate is (1S, cis)- 4-[ 2- amino- 6- (cyclopropylamino)- 9H- purin- 9- yl]- 2- cyclopentene- 1- methanol sulfate (salt) (2: 1)
author: Virginia Yoerg
V:\DAVDP\CSO\YOERG\NDA\Crimson\21-205triz\SLRs\cbe003.004\apltr\ .doc page 2
author: Virginia Yoerg
V:\DAVDP\CSO\YOERG\NDA\Crimson\21-205triz\SLRs\slr006\approvall\ tr.doc TRIZIVIR (abacavir sulfate, lamivudine, and zidovudine) Tablets 3 PRODUCT INFORMATION TRIZIVIR (abacavir sulfate, lamivudine, and zidovudine) Tablets WARNING: TRIZIVIR contains 3 nucleoside analogs (abacavir sulfate, lamivudine, and zidovudine) and is intended only for patients whose regimen would otherwise include these 3 componentsAbacavir Sulfate: ...
author: Virginia Yoerg
V:\DAVDP\CSO\YOERG\NDA\Crimson\21-205triz\SLRs\slr006\approvall\ tr.doc page 2
author: Virginia Yoerg
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...
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 N21205...
EFFICACY SUPPLEMENTS APPROVED IN CY 2000 EFFICACY SUPPLEMENTS APPROVED IN CY 2000 GENERIC NAME APPLICANT NDA NUMBER RECEIPT DATE APPROVAL DATE SUPP TYPE SUPP NUMBER PRIORITY REVIEW TOTAL APPROVAL TIME (MONTHS) INDICATION/DESCRIPTION IBUPROFEN WHITEHALL ROBINS 20-812 15-Jun-98 12-Jan-00 SE5 003 N 18.9 Provides for the use of Infants' Advil (ibuprofen oral suspension) Concentrated Oral Drops, 50 mg/1.25 mL for ages 6 months...
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 bladder with...
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...
Human Immunodeficiency Virus Infection: Merck Manual Home Edition Drugs For HIV Infection Type Drug Side Effects Non-nucleoside reverse transcriptase inhibitors - Delavirdine Rash, headaches - Efavirenz Dizziness, sleepiness, nightmares, confusion, agitation, forgetfulness, euphoria, rash - Nevirapine Rash (occasionally severe or life threatening), liver dysfunction Nucleoside and nucleotide reverse transcriptase inhibitors - - All may cause lactic...
