Kaletra
These highlights do not include all the information needed to use KALETRA safely and effectively. See full prescribing information for KALETRA. KALETRA (lopinavir and ritonavir) Tablet, Film Coated for Oral use KALETRA (lopinavir and ritonavir) Solution for Oral useInitial U.S. Approval: 2000
Approved
Approval ID
0b126fcd-2385-409f-9269-5bf886649c1a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 6, 2012
Manufacturers
FDA
HHS/Program Support Center/Supply Service Center
DUNS: 194032918
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Lopinavir and Ritonavir
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code11819-342
Application NumberNDA021906
Product Classification
M
Marketing Category
C73594
G
Generic Name
Lopinavir and Ritonavir
Product Specifications
Route of AdministrationORAL
Effective DateMarch 6, 2012
FDA Product Classification
INGREDIENTS (14)
RitonavirActive
Quantity: 50 mg in 1 1
Code: O3J8G9O825
Classification: ACTIB
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
LopinavirActive
Quantity: 200 mg in 1 1
Code: 2494G1JF75
Classification: ACTIB
SORBITAN MONOLAURATEInactive
Code: 6W9PS8B71J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT