Last Updated: September 24, 2026

Details for New Drug Application (NDA): 202136

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NDA 202136 describes DARUNAVIR, which is a drug marketed by Amneal, Annora Pharma, Aurobindo Pharma Ltd, Cipla, Dr Reddys, Hetero Labs Ltd Iii, Lupin, 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 is one drug master file entry for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the darunavir profile page.

Summary for 202136

Tradename:	DARUNAVIR
Applicant:	Mylan
Ingredient:	darunavir
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	75MG
Approval Date:	Jul 22, 2025	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	150MG
Approval Date:	Jul 22, 2025	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	300MG
Approval Date:	Jul 22, 2025	TE:		RLD:	No

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