Kaletra

Product NDC

70518-0091

11-digit product format

705180091

Labeler code

70518

Product ID

70518-0091_d2a9d223-db43-7ada-e053-2995a90a7dea

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Lopinavir and Ritonavir

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

REMEDYREPACK INC.

Application

NDA021906

Marketing category

NDA

Marketing start

2016-12-29

Marketing end

0000-00-00

Substance

LOPINAVIR; RITONAVIR

Active strength

200 mg/1; mg/1

Pharmacologic classes

HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],HIV Protease Inhibitors [MoA],Cytochrome P450 3A Inhibitor [EPC],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],P-Glycoprotein Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],UDP Glucuronosyltransferases Inducers [MoA]

NDC exclude flag

No

Listing certified through

2022-12-31

Current FDA listing

Historical FDA.report record