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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 202118

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NDA 202118 describes DARUNAVIR, which is a drug marketed by Amneal, Annora Pharma, Aurobindo Pharma Ltd, Cipla, Dr Reddys, Hetero Labs Ltd Iii, Lupin Ltd, MSN, Mylan, Teva Pharms Usa, and Zydus Lifesciences, and is included in eleven NDAs. It is available from thirteen suppliers. Additional details are available on the DARUNAVIR profile page.

The generic ingredient in DARUNAVIR is darunavir. There are twenty-five drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the darunavir profile page.

Summary for 202118

Tradename:	DARUNAVIR
Applicant:	Teva Pharms Usa
Ingredient:	darunavir
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	600MG
Approval Date:	Nov 21, 2017	TE:		RLD:	No

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