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

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