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FDA Approval Activities for this Drug…
RETROVIR (zidovudine) IV Infusion, GlaxoSmithKline NDA 19-951/S-019 7/25/03 8/15/03 8/15/03 | RETROVIR (zidovudine) IV Infusion GlaxoSmithKline NDA 19-951/S-018 7/25/03 8/6/03 8/6/03 | RETROVIR (zidovudine) IV Infusion GlaxoSmithKline NDA 19-951/S-017 2/21/02 2/21/02 | RETROVIR (zidovudine) IV Infusion GlaxoSmithKline NDA 19-951/S-016 9/12/01 6/10/03 | RETROVIR (zidovudine) Capsules, Syrup, & Tablets, GlaxoSmithKline NDA 19-655/S039, 19-910/S027, & 20-528/S011 10/15/03 10/17/03 10/17/03 | RETROVIR (zidovudine) Capsules, Syrup, & Tablets, GlaxoSmithKline NDA 19-655/S038, 19-910/S026, & 20-518/S010 12/18/02 1/29/03 4/4/03 | RETROVIR (zidovudine) Capsules, Syrup, & Tablets. GlaxoSmithKline NDA 19-655/S037, 19-910/S025, & 20-518/S009 2/21/02 2/21/02 | RETROVIR (zidovudine) Capsules, Syrup, & Tablets. GlaxoSmithKline NDA 19-655/S036 10/5/01 6/16/03 | RETROVIR (zidovudine) Capsules, Syrup, & Tablets. GlaxoSmithKline NDA 19-655/S032, 19-910/S021, 20-518/S004 3/30/01 4/26/01 4/26/01 | RETROVIR (zidovudine) Capsules, Syrup, & Tablets. GlaxoSmithKline NDA 20-518/S8 Combivir (lamivudine/zidovudine) tablets, GlaxoSmithKline | Lamivudine/Zidovudine Tablets co-packaged w/Nevirapine Tablets, Pharmacare Limited, Tentative Approval | Lamivudine and Zidovudine Tablets, Aurobindo Pharma, Approval | Zidovudine Tablets, Roxane Labs, Tentative Approval | Zidovudine Tablets, Aurobindo Pharma, Tentative Approval | Zidovudine Oral Solution, Aurobindo Pharma, Tentative Approval | Zidovudine Syrup, Aurobindo Pharma Limited, Inc., Approval | Zidovudine Tablets, Aurobindo Pharma Limited, Inc., Approval | Zidovudine Tablets, Roxane Laboratories Inc., Approval | Zidovudine Tablets, Ranbaxy, Inc., Approval | Lamivudine 150mg/Zidovudine 300mg Fixed- Dose Tablets co-packaged w/Efavirenz 600mg Tablets, Aurbindo Pharma, Tentative Approval | Zidovudine Capsules, Aurobindo Pharma, Approval | RETROVIR (zidovudine) Capsules, GlaxoSmithKline, Labeling Revision | RETROVIR Syrup (zidovudine), GlaxoSmithKline, Labeling Revision | RETROVIR Tablets (zidovudine), GlaxoSmithKline, Labeling Revision | Combivir (lamivudine/zidovudine) Tablets, GlaxoSmithKline, Labeling Revision | RETROVIR (zidovudine) IV Solution, GlaxoSmithKline, Labeling Revision | Lamivudine 150mg/Zidovudine 300mg Tablets Co-Packaged with Abacavir Sulfate 300mg Tablets, Aurobindo Pharma, Approval | 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 | RETROVIR (zidovudine) IV Infusion, GlaxoSmithKline, Labeling Revision | RETROVIR (zidovudine) Capsules, GlaxoSmithKline, Labeling Revision | RETROVIR (zidovudine) Syrup, GlaxoSmithKline, Labeling Revision | Lamivudine/Zidovudine Tablets co-packaged w/Nevirapine Tablets, Pharmacare Ltd., Tentative Approval | Lamivudine/Zidovudine/Nevirapine Tablets, Aurobindo Pharma, Approval | Lamivudine/Zidovudine/Nevirapine Tablets, Cipla Ltd., Tentative Approval | COMBIVIR (lamivudine/ zidovudine) Tablets, GlaxoSmithKline, Labeling Revision | Zidovudine Capsules, Cipla Ltd., Approval | Lamivudine and Zidovudine Tablets, Matrix Labs, Tentative Approval | Zidovudine Tablets, Mylan Pharma, Tentative Approval | Zidovudine Syrup, Cipla, Ltd., Approval | RETROVIR (zidovudine) Capsules, GlaxoSmithKline, New Dosage Regimen | RETROVIR (zidovudine) Syrup, GlaxoSmithKline, New Dosage Regimen | RETROVIR (zidovudine) Tablets, GlaxoSmithKline, New Dosage Regimen | COMBIVIR (lamivudine and zidovudine) Tablets, GlaxoSmithKline, Patient Population Altered | Trizivir (abacavir sulfate, lamivudine, and zidovudine) Tablets, GlaxoSmithKline, Labeling Revision | Lamivudine and Zidovudine Tablets, Hetero Drugs Ltd. Unit III, Tentative Approval | Lamivudine and Zidovudine Tablets, Aurobindo Pharma Limited, Tentative Approval | Zidovudine Tablets, Aurobindo Pharma Limited, Approval | RETROVIR (zidovudine) Capsules, GlaxoSmithKline, Labeling Revision | RETROVIR (zidovudine) Syrup, GlaxoSmithKline, Efficacy Supp. w/Clinical Data | Lamivudine and Zidovudine Tablets, TEVA Pharmaceuticals, Tentative Approval | Retrovir (zidovudine) Capsules, GlaxoSmithKline, Labeling Revision | Retrovir (zidovudine) Syrup, GlaxoSmithKline, Labeling Revision | Retrovir (zidovudine) Tablets, GlaxoSmithKline, Labeling Revision | Trizivir (abacavir sulfate, lamivudine, and zidovudine) Tablets, ViiV Healthcare Company, Supplement | COMBIVIR (lamivudine/zidovudine) Tablets, GlaxoSmithKline, Labeling Revision | Zidovudine Tablets, Cipla Limited, Approval | Lamivudine and Zidovudine Tablets, Strides Arcolab Ltd., Tentative Approval | Lamivudine and Zidovudine Tablets, Matrix Laboratories, Ltd., Tentative Approval | Zidovudine Tablets, Matrix Laboratories Ltd., Approval | Trizivir (abacavir sulfate, lamivudine and zidovudine) Tablets, GlaxoSmithKline, Labeling Revision | Lamivudine and Zidovudine Tablets, TEVA Pharmaceuticals, Approval | Lamivudine and Zidovudine Tablets, Cipla Limited, Tentative Approval | Zidovudine Tablets, HEC Pharm, Inc., Approval | Lamivudine and Zidovudine Tablets, Lupin, Ltd., Tentative Approval | Retrovir (zidovudine) IV Infusion, GlaxoSmithKline, Labeling Revision | Retrovir (zidovudine) Capsules, GlaxoSmithKline, Labeling Revision | Retrovir (zidovudine) Syrup, GlaxoSmithKline, Labeling Revision | Retrovir (zidovudine) Tablets, GlaxoSmithKline, Labeling Revision | Combivir (lamivudine and zidovudine) Tablets, GlaxoSmithKline, Labeling Revision | Lamivudine, Nevirapine, and Zidovudine Tablets, Hetero Labs Limited Unit III, Tentative Approval
  
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