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FDA Approval Activities for this Drug…
Combivir (lamivudine/zidovudine) Tablets, 150mg and 300mg GlaxoSmithKline NDA 20-857/S-012 10/8/02 10/11/01 10/8/02 | Combivir (lamivudine/zidovudine) Tablets, 150mg and 300mg GlaxoSmithKline NDA 20-857/S-009 & 20-857/S-010 | Epivir (lamivudine), Tablets and solution, 150mg, GlaxoSmithKline NDA 20-564/S-016 & 20-596/S-017 3/1/02 3/5/02 | Epivir (lamivudine), Tablets and solution, 150mg, GlaxoSmithKline NDA 20-564/S-015 & 20-596/S-016 6/24/02 7/2/02 6/25/02 | Epivir (lamivudine), Tablets and solution, 150mg, GlaxoSmithKline NDA 20-564/S-014 & 20-596/S-015 10/8/02 10/11/01 10/8/02 | Epivir (lamivudine), Tablets and solution, 150mg, GlaxoSmithKline NDA 20-564/S-012 & 20-596/S-013 3/6/01 4/26/01 | Epivir-HBV (Lamivudine) Tablets & Solution, 100 mg & 5 mg/mL, GlaxoSmithKline NDA 21-003/S2 & 21-004/S2 Epivir (lamivudine), Tablets and solution, GlaxoSmithKline | Epivir-HBV (Lamivudine) Tablets & Solution, GlaxoSmithKline Combivir (lamivudine/zidovudine) tablets, GlaxoSmithKline | EPZICOM [abacavir sulfate (equivalent to 600 mg abacavir) and lamivudine (300 mg)] fixed dose combination Tablets, GlaxoSmithKline, Approval | EPIVIR- HBV (lamivudine) tablets, GlaxoSmithKline, Labeling Revision | EPIVIR- HBV (lamivudine) oral solution, GlaxoSmithKline, Labeling Revision | Combivir (lamivudine/zidovudine) tablets, GlaxoSmithKline, Labeling Revision | EPIVIR (lamivudine) oral solution, GlaxoSmithKline, Labeling Revision | EPIVIR (lamivudine) tablets, GlaxoSmithKline, Labeling Revision | EPIVIR (lamivudine) tablets, GlaxoSmithKline, Labeling Revision | EPIVIR (lamivudine) oral solution, GlaxoSmithKline, Labeling Revision | EPIVIR- HBV (lamivudine) tablets, GlaxoSmithKline, Labeling Revision | EPIVIR- HBV (lamivudine) oral solution, GlaxoSmithKline, Labeling Revision | Lamivudine/Zidovudine Tablets co-packaged w/Nevirapine Tablets, Pharmacare Limited, Tentative Approval | Lamivudine Tablets, Ranbaxy Labs, Tentative Approval | Lamivudine Tablets, Aurobindo Pharma, Tentative Approval | Lamivudine and Zidovudine Tablets, Aurobindo Pharma, Approval | Lamivudine Oral Solution, Aurobindo Pharma, Tentative Approval | Epivir (lamivudine) Tablets, GlaxoSmithKline, Labeling Revision | Epivir (lamivudine) Oral Solution, GlaxoSmithKline, Labeling Revision | Lamivudine Oral Solution, Cipla Ltd., Tentative Approval | Combivir (lamivudine/zidovudine) Tablets, GlaxoSmithKline, Labeling Revision | 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 | Lamivudine and Zidovudine Tablets, Aurobindo Pharma, Tentative Approval | Lamivudine/Zidovudine Tablets, Cipla Ltd., Tentative Approval | COMBIVIR (lamivudine/ zidovudine) tablets, GlaxoSmithKline, Labeling Revision | EPIVIR (lamivudine) oral solution, GlaxoSmithKline, Labeling Revision | EPIVIR (lamivudine) tablets, GlaxoSmithKline, Labeling Revision | Lamivudine, Stavudine, Nevirapine Tablets, Cipla Ltd., Tentative Approval | Lamivudine/Zidovudine Tablets co-packaged w/Nevirapine Tablets, Pharmacare Ltd., Tentative Approval | Lamivudine Stavudine Tablets, Cipla Ltd., Tentative Approval | Lamivudine/Zidovudine/Nevirapine Tablets, Aurobindo Pharma, Approval | Lamivudine/Zidovudine/Nevirapine Tablets, Cipla Ltd., Tentative Approval | Stavudine/Lamivudine Tablets Co-packaged with Nevirapine Tablets, Strides Arcolab, Tentative Approval | Stavudine/Lamivudine Tablets, Strides Arcolab, Tentative Approval | Lamivudine Tablets, Matrix Labs, Tentative Approval | COMBIVIR (lamivudine/ zidovudine) Tablets, GlaxoSmithKline, Labeling Revision | Epzicom (abacavir sulfate and lamivudine) Tablets, GlaxoSmithKline, Labeling Revision | Stavudine/Lamivudine Tablets Co-packaged w/Efavirenz Tablets, Strides, Tentative Approval | Lamivudine/Stavudine/Nevirapine Dispersible Tablets, Cipla Ltd., Tentative Approval | Lamivudine Tablets, Aurobindo Pharma, Tentative Approval | EPIVIR-HBV (lamivudine) Tablets, GlaxoSmithKline, Labeling Revision | EPIVIR-HBV (lamivudine) Oral Solution, GlaxoSmithKline, Labeling Revision | Lamivudine/Stavudine Tablets, Matrix Labs, Tentative Approval | Lamivudine and Zidovudine Tablets, Matrix Labs, Tentative Approval | Lamivudine Tablets, InvaGen Pharma, Tentative Approval | EPIVIR (lamivudine) Scored Tablets, GlaxoSmithKline, Patient Population Altered | Stavudine/Lamivudine/Nevirapine Tablets, Strides Arcolab, Tentative Approval | Lamivudine Tablets, Ranbaxy, Tentative Approval | Lamivudine/Stavudine Tablets, Cipla Ltd., Tentative Approval | Abacavir Sulfate and Lamivudine Tablets, Aurobindo Pharma USA, Inc., Tentative Approval | Lamivudine and Tenofovir Disoproxil Fumarate Tablets, Matrix Laboratories, Ltd., Tentative Approval | Abacavir Sulfate and Lamivudine Tablets, Aurobindo Pharma Ltd., Tentative Approval | COMBIVIR (lamivudine and zidovudine) Tablets, GlaxoSmithKline, Patient Population Altered | Stavudine, Lamivudine and Nevirapine Tablets, Pharmacare Ltd., Tentative Approval | 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 | Lamivudine and Zidovudine Tablets, Hetero Drugs Ltd. Unit III, Tentative Approval | Lamivudine Tablets, Matrix Laboratories Ltd., Tentative Approval | Stavudine, Lamivudine, and Nevirapine Tablets, Emcure Pharmaceuticals, Ltd., Tentative Approval | Lamivudine and Zidovudine Tablets, Aurobindo Pharma Limited, Tentative Approval | Lamivudine Tablets, Strides Arcolab, Ltd., Tentative Approval | Lamivudine and Zidovudine Tablets, TEVA Pharmaceuticals, Tentative Approval | Abacavir Sulfate and Lamivudine Tablets, Teva Pharmaceuticals, Tentative Approval | Lamivudine and Stavudine Tablets, Hetero Drugs Ltd., Tentative Approval | Epzicom (abacavir sulfate and lamivudine) Tablets, ViiV Healthcare Company, Supplement | Trizivir (abacavir sulfate, lamivudine, and zidovudine) Tablets, ViiV Healthcare Company, Supplement | Lamivudine, Nevirapine, and Stavudine Tablets, Macleods Pharmaceuticals Ltd., Tentative Approval | COMBIVIR (lamivudine/zidovudine) Tablets, GlaxoSmithKline, Labeling Revision | Lamivudine and Zidovudine Tablets, Strides Arcolab Ltd., Tentative Approval | Lamivudine and Zidovudine Tablets, Matrix Laboratories, Ltd., Tentative Approval | Epivir-HBV (lamivudine) Tablets, GlaxoSmithKline LLC, Labeling Revision | Epivir-HBV (lamivudine) Oral Solution, GlaxoSmithKline LLC, Labeling Revision | Epzicom (abacavir sulfate and lamivudine) Tablets, GlaxoSmithKline, Labeling Revision | Lamivudine and Tenofovir Disoproxil Fumarate Tablets, Cipla Ltd., Tentative Approval | Lamivudine Tablets, TEVA Pharmaceuticals, 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 | Lamivudine and Zidovudine Tablets, TEVA Pharmaceuticals, Approval | Lamivudine, Tenofovir Disoproxil Fumarate and Nevirapine Tablets, Matrix Laboratories, Ltd., Tentative Approval | Lamivudine and Zidovudine Tablets, Cipla Limited, Tentative Approval | Lamivudine and Zidovudine Tablets, Lupin, Ltd., Tentative Approval | Lamivudine Tablets, Aurobindo Pharma, Ltd., Approval | Combivir (lamivudine and zidovudine) Tablets, GlaxoSmithKline, Labeling Revision | Lamivudine, Nevirapine, and Zidovudine Tablets, Hetero Labs Limited Unit III, Tentative Approval | Epzicom (abacavir sulfate and lamivudine) Tablets, GlaxoSmithKline, Labeling Revision | Lamivudine Tablets, Apotex, Inc., Approval
  
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