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FDA Approval Activities for this Drug…
Kaletra (lopinavir) oral solution, lopinavir/ ritonavir.Patient Package Insert. Abbott 21-251 9/15/00 9/18/00 9/18/00 3/26/02 Kaletra Indication:Kaletra is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infections in adults and pediatric patients age six months and older. Kaletra (lopinavir/ritonavir) Abbott 21-226/S6 & 21-251/S5 11/27/02 12/4/02 Kaletra (lopinavir/ritonavir) Abbott 21-226/S3 & 21-251/S4 1/18/02 2/5/02 2/5/02 3/26/02 Kaletra (lopinavir/ritonavir) Capsules & Solution, 133.3/33. Capsules and 80/ Solution., Abbott 21-226/S2 & 21-251/S2 3/13/01 4/25/01 3/26/02 3/26/02 Kaletra (lopinavir) 133. lopinavir/33. ritonavir. Patient Package Insert Abbott 21-226 9/15/00 9/18/00 9/18/00 3/26/02 Kaletra Indication: Kaletra is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infections in adults and pediatric patients age six months and older. Kaletra (lopinavir/ritonavir) Abbott Laboratories | KALETRA (lopinavir/ritonavir) capsules, Abbott Labs, Labeling Revision | KALETRA (lopinavir/ritonavir) oral solution, Abbott Labs, Labeling Revision | KALETRA (lopinavir/ritonavir) capsules, Abbott Labs, New Dosage Regimen | KALETRA (lopinavir/ritonavir) tablets, Abbott Labs, Approval | KALETRA (lopinavir/ritonavir) tablet, Abbott Labs, Labeling Revision | KALETRA (lopinavir/ritonavir) oral solution, Abbott Labs, Labeling Revision | KALETRA (lopinavir/ritonavir) capsules, Abbott Labs, Labeling Revision | Kaletra (lopinavir/ritonavir) Oral Solution, Abbott Labs, Labeling Revision | Kaletra (lopinavir/ritonavir) Tablets, Abbott Labs, Labeling Revision | KALETRA (Lopinavir/ Ritonavir) Oral, Abbott Labs, Efficacy Supp. w/Clinical Data | KALETRA (Lopinavir/Ritonavir) Tablets, Abbott Labs, Efficacy Supp. w/Clinical Data | Kaletra (lopinavir/ritonavir) Oral Solution, Abbott Labs, Labeling Revision | Kaletra (lopinavir/ ritonavir) Tablets, Abbott Labs, Labeling Revision | Kaletra (lopinavir/ritonavir) Capsules, Abbott Labs, Labeling Revision | KALETRA (lopinavir/ritonavir) Capsules, Abbott Labs, Labeling Revision | KALETRA (lopinavir/ritonavir) Tablets, Abbott Labs, Labeling Revision | KALETRA (lopinavir/ritonavir) Oral Solution, Abbott Labs, Labeling Revision | KALETRA (lopinavir/ritonavir) Oral Solution, Abbott Labs, New Dosage Regimen | KALETRA (lopinavir/ritonavir) Tablets, Abbott Labs, New Dosage Regimen | KALETRA (lopinavir and ritonavir) Oral Solution, Abbott Laboratories, Patient Population Altered | KALETRA (lopinavir and ritonavir) Tablets, Abbott Laboratories, Labeling Revision | Kaletra (lopinavir and ritonavir) Oral Solution, Abbott Laboratories, Labeling Revision | Kaletra (lopinavir and ritonavir) Oral Solution, Abbott Laboratories, Labeling Revision | Kaletra (lopinavir and ritonavir) Tablets, Abbott Laboratories, Labeling Revision | Lopinavir and Ritonavir Tablets, Matrix Laboratories, Ltd., Tentative Approval | Lopinavir and Ritonavir Tablets, Aurobindo Pharma, Ltd., Tentative Approval | KALETRA (lopinavir and ritonavir) Tablets, Abbott Laboratories, Labeling Revision | KALETRA (lopinavir and ritonavir) Oral Solution, Abbott Laboratories, Labeling Revision | Kaletra (lopinavir and ritonavir) Tablets, Abbott Laboratories, Efficacy Supplement with Clinical Data to Support | Kaletra (lopinavir and ritonavir) Oral Solution, Abbott Laboratories, Efficacy Supplement with Clinical Data to Support | Lopinavir and Ritonavir Tablets, Cipla Ltd., Tentative Approval | Kaletra (lopinavir and ritonavir) Tablets, Abbott Laboratories, Labeling Revision | Kaletra (lopinavir and ritonavir) Oral Solution, Abbott Laboratories, Labeling Revision | Kaletra (lopinavir and ritonavir) Tablets, Abbott Laboratories, Patient Population Altered | Kaletra (lopinavir and ritonavir) Oral Solution, Abbott Laboratories, Patient Population Altered | Kaletra (lopinavir and ritonavir) Oral Solution, Abbott Laboratories, Labeling Revision | Kaletra (lopinavir and ritonavir) Tablets, Abbott Laboratories, Labeling Revision | Kaletra (lopinavir and ritonavir) Tablets, Abbott Laboratories, Labeling Revision | Kaletra (lopinavir and ritonavir) Oral Solution, Abbott Laboratories, Labeling Revision | Kaletra (lopinavir and ritonavir) Tablets, Abbott Laboratories, Labeling Revision | Kaletra (lopinavir and ritonavir) Oral Solution, Abbott Laboratories, Labeling Revision | Lopinavir and Ritonavir Tablets, Mylan Pharmaceuticals, Inc., Tentative Approval
  
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