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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 | Abacavir Sulfate and Lamivudine Tablets, Teva Pharmaceuticals, Tentative Approval | Abacavir Sulfate Tablets, Strides Arcolab, Ltd., Tentative Approval | Epzicom (abacavir sulfate and lamivudine) Tablets, ViiV Healthcare Company, Supplement | Trizivir (abacavir sulfate, lamivudine, and zidovudine) Tablets, ViiV Healthcare Company, Supplement | Ziagen (abacavir sulfate) Oral Solution, ViiV Healthcare Company, Supplement | Ziagen (abacavir sulfate) Tablets, ViiV Healthcare Company, Supplement | Abacavir Sulfate Tablets, InvaGen Pharmaceuticals, Inc., Tentative Approval | Abacavir Sulfate Tablets, Matrix Laboratories, Ltd., Tentative Approval | Epzicom (abacavir sulfate and lamivudine) Tablets, GlaxoSmithKline, Labeling Revision | Abacavir Sulfate Oral Solution, Cipla Ltd., Tentative Approval | Abacavir Sulfate Tablets, Mylan Pharmaceuticals, Inc., Tentative Approval | Trizivir (abacavir sulfate, lamivudine and zidovudine) Tablets, GlaxoSmithKline, Labeling Revision | Abacavir Sulfate and Lamivudine Oral Suspension Tablets, Cipla, Ltd., Tentative Approval | Epzicom (abacavir sulfate and lamivudine) Tablets, GlaxoSmithKline, Labeling Revision | Trizivir (abacavir sulfate, lamivudine, and zidovudine) Tablets, GlaxoSmithKline, Labeling Revision | Ziagen (abacavir sulfate) Tablets, GlaxoSmithKline, Labeling Revision | Ziagen (abacavir sulfate) Oral Solution, GlaxoSmithKline, Labeling Revision | Trizivir (abacavir sulfate, lamivudine, and zidovudine) Tablets, GlaxoSmithKline, Labeling Revision | Ziagen (abacavir sulfate) Oral Solution, GlaxoSmithKline, Labeling Revision | Ziagen (abacavir sulfate) Oral Solution, GlaxoSmithKline, Labeling Revision | Epzicom (abacavir sulfate and lamivudine) Tablets, GlaxoSmithKline, Labeling Revision
  
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