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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 | Abacavir Sulfate Tablets, Matrix Labs, Tentative Approval | Epzicom (abacavir sulfate and lamivudine) Tablets, GlaxoSmithKline, Labeling Revision | ZIAGEN (abacavir sulfate) Tablets, GlaxoSmithKline, Efficacy Supplement with Clinical Data to Support | ZIAGEN (abacavir sulfate) Oral Solution, GlaxoSmithKline, Efficacy Supplement with Clinical Data to Support | Abacavir Sulfate and Lamivudine Tablets, Aurobindo Pharma USA, Inc., Tentative Approval | Abacavir Sulfate and Lamivudine Tablets, Aurobindo Pharma Ltd., Tentative Approval | Ziagen (abacavir sulfate) Oral Solution, GlaxoSmithKline, Labeling Revision | Ziagen (abacavir sulfate) Tablets, GlaxoSmithKline, New Dosage Regimen | Epzicom (abacavir sulfate and lamivudine) Tablets, GlaxoSmithKline, Labeling Revision | Trizivir (abacavir sulfate, lamivudine, and zidovudine) Tablets, GlaxoSmithKline, Labeling Revision | Abacavir Sulfate and Lamivudine Tablets, Matrix Laboratories, Ltd., Tentative Approval
  
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