Last Updated: November 8, 2026

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, Micro Labs, and Mylan Labs Ltd, and is included in six NDAs. It is available from three suppliers. Additional details are available on the LOPINAVIR AND RITONAVIR profile page.

The generic ingredient in LOPINAVIR AND RITONAVIR is lopinavir; ritonavir. There is one drug master file entry for this compound. Four 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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