Key Data Files for this Active Pharmaceutical Ingredient:

Drug Master Files, 21 CFR, and other industry portals Patent/Exclusivity data file Drug Approval Drug Safety Freedom of Information Federal Register pages Pharma Companies Pharmacopeial Information Preferred API Supplier (Clients Only)

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   For the latest approval information, locate this drug using this index.