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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 079074

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NDA 079074 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 four 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. Five suppliers are listed for this compound. Additional details are available on the lopinavir; ritonavir profile page.

Summary for 079074

Tradename:	LOPINAVIR AND RITONAVIR
Applicant:	Mylan Labs Ltd
Ingredient:	lopinavir; ritonavir
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG;25MG
Approval Date:	Feb 7, 2024	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG;50MG
Approval Date:	Feb 7, 2024	TE:	AB	RLD:	No

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