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Last Updated: April 25, 2024

Details for New Drug Application (NDA): 021906

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NDA 021906 describes KALETRA, which is a drug marketed by Abbvie and is included in three NDAs. It is available from two suppliers. Additional details are available on the KALETRA profile page.

The generic ingredient in KALETRA is lopinavir; ritonavir. There are thirteen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the lopinavir; ritonavir profile page.

Summary for 021906

Tradename:	KALETRA
Applicant:	Abbvie
Ingredient:	lopinavir; ritonavir
Patents:	0

Pharmacology for NDA: 021906

Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Cytochrome P450 1A2 Inducers Cytochrome P450 2B6 Inducers Cytochrome P450 2C19 Inducers Cytochrome P450 2C9 Inducers Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A Inducers Cytochrome P450 3A Inhibitors Cytochrome P450 3A4 Inhibitors HIV Protease Inhibitors Organic Anion Transporting Polypeptide 1B1 Inhibitors P-Glycoprotein Inhibitors UDP Glucuronosyltransferases Inducers

Suppliers and Packaging for NDA: 021906

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
KALETRA	lopinavir; ritonavir	TABLET;ORAL	021906	NDA	AbbVie Inc.	0074-0522	0074-0522-60	60 TABLET, FILM COATED in 1 BOTTLE (0074-0522-60)
KALETRA	lopinavir; ritonavir	TABLET;ORAL	021906	NDA	AbbVie Inc.	0074-4014	0074-4014-12	120 TABLET, FILM COATED in 1 BOTTLE (0074-4014-12)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG;50MG
Approval Date:	Oct 28, 2005	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG;25MG
Approval Date:	Nov 9, 2007	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021906

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	KALETRA	lopinavir; ritonavir	TABLET;ORAL	021906-001	Oct 28, 2005	⤷ Try a Trial	⤷ Try a Trial
Abbvie	KALETRA	lopinavir; ritonavir	TABLET;ORAL	021906-001	Oct 28, 2005	⤷ Try a Trial	⤷ Try a Trial
Abbvie	KALETRA	lopinavir; ritonavir	TABLET;ORAL	021906-002	Nov 9, 2007	⤷ Try a Trial	⤷ Try a Trial
Abbvie	KALETRA	lopinavir; ritonavir	TABLET;ORAL	021906-002	Nov 9, 2007	⤷ Try a Trial	⤷ Try a Trial
Abbvie	KALETRA	lopinavir; ritonavir	TABLET;ORAL	021906-002	Nov 9, 2007	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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