Content specific to this active ingredient… Drug Information Prescribing and patient information from leading authorities Drug Master Files Type 2 master files on file at the FDA Drug Recalls For prescription drugs containing this active ingredient Exclusivity Patent and market exclusivity data Federal Register FR search results for this API FDA Approved Labelling Information found in this drug's package inserts Research Links Chemical identification and research citations Title 21 Code of Federal Regulations FDA regulations for this API

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 ^ FDA's latest approval appears at the bottom of this 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