Details for New Drug Application (NDA): 213857

NDA 213857 describes LOPINAVIR AND RITONAVIR, which is a drug marketed by Lannett Co Inc, Hetero Labs Ltd Iii, Laurus, Macleods Pharms Ltd, and Mylan Labs Ltd, and is included in five NDAs. It is available from five suppliers. Additional details are available on the LOPINAVIR AND RITONAVIR profile page.

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

Summary for 213857

Tradename:	LOPINAVIR AND RITONAVIR
Applicant:	Laurus
Ingredient:	lopinavir; ritonavir
Patents:	0

Pharmacology for NDA: 213857

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: 213857

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LOPINAVIR AND RITONAVIR	lopinavir; ritonavir	TABLET;ORAL	213857	ANDA	Laurus Labs Limited	42385-933	42385-933-60	60 TABLET, FILM COATED in 1 BOTTLE (42385-933-60)
LOPINAVIR AND RITONAVIR	lopinavir; ritonavir	TABLET;ORAL	213857	ANDA	Laurus Labs Limited	42385-934	42385-934-12	120 TABLET, FILM COATED in 1 BOTTLE (42385-934-12)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG;25MG
Approval Date:	Mar 21, 2022	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG;50MG
Approval Date:	Mar 21, 2022	TE:	AB	RLD:	No

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