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FDA Approval Activities for this Drug…
Trizivir (abacavir sulfate, lamivudine, zidovudine) Tablets, GlaxoSmithKline NDA 21-205/S-007 10/8/02 10/11/01 10/8/02 Trizivir (abacavir sulfate, lamivudine, zidovudine) Tablets, GlaxoSmithKline NDA 21-205/S-006 8/13/02 8/21/02 8/14/02 Trizivir (abacavir sulfate, lamivudine, zidovudine), GlaxoWellcome NDA 21-205/S-003 6/4/02 6/7/02 Trizivir (abacavir sulfate, lamivudine, zidovudine), GlaxoSmithKline NDA 21-205/S-002 2/5/02 4/16/02 Trizivir (abacavir sulfate, lamivudine, zidovudine), Glaxo Wellcome NDA 21-205 11/14/00 6/17/02 Trizivir Indications: for the treatment of HIV-1 Infection Ziagen (abacavir sulfate) Tablets and Solution, GlaxoSmithKline NDA 20-977/S10 & NDA 20-978/S12 7/17/03 7/28/03 9/25/03 Ziagen (abacavir sulfate) Tablets and Solution, GlaxoSmithKline NDA 20-977/S8 & NDA 20-978/S10 8/14/02 8/21/02 8/14/02 Ziagen (abacavir sulfate) Tablets and Solution, GlaxoSmithKline NDA 20-977/S7 & NDA 20-978/S8 10/2/02 10/11/01 10/3/02 Ziagen (abacavir sulfate) Tablets and Solution, GlaxoSmithKline NDA 20-977/S5 & NDA 20-978/S6 1/28/02 3/6/02 Ziagen (abacavir sulfate) Tablets and Solution, Glaxo Wellcome NDA 20-977 & NDA 20-978 12/17/98 1/6/99 1/6/99 4/4/02 Ziagen Indications: For the treatment of HIV-1 infection in adults and children (ages 3 months and above). This indication is based on analyses of surrogate markers in controlled studies up to 24 weeks in duration. ZIAGEN (abacavir sulfate) Oral Solution, GlaxoSmithKline, Labeling Revision ZIAGEN (abacavir sulfate) Tablets, GlaxoSmithKline, Labeling Revision ZIAGEN (abacavir sulfate) tablets, GlaxoSmithKline, New Dosage Regimen ZIAGEN (abacavir sulfate) oral solution, GlaxoSmithKline, New Dosage Regimen EPZICOM [abacavir sulfate (equivalent to 600 mg abacavir) and lamivudine (300 mg)] fixed dose combination Tablets, GlaxoSmithKline, Approval | TRIZIVIR (abacavir sulfate, lamivudine, and zidovudine) Tablets, GlaxoSmithKline, Accelerated Approval | Abacavir Sulfate Tablets, Aurobindo Pharma, Tentative Approval | Abacavir Sulfate Oral Solution, Aurobindo Pharma, Tentative Approval | Lamivudine 150mg/Zidovudine 300mg Tablets Co-Packaged with Abacavir Sulfate 300mg Tablets, Aurobindo Pharma, Approval | Epzicom (abacavir sulfate/lamivudine) tablets, GlaxoSmithKline, Labeling Revision | Trizivir (abacavir sulfate/lamivudine/zidovudine) tablets, GlaxoSmithKline, Labeling Revision | Ziagen (abacavir sulfate) tablets and oral solution, GlaxoSmithKline, Labeling Revision | Abacavir Sulfate Tablets, Cipla Ltd., Tentative Approval
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