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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 216168

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NDA 216168 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 216168

Tradename:	DARUNAVIR
Applicant:	Annora Pharma
Ingredient:	darunavir
Patents:	0

Pharmacology for NDA: 216168

Mechanism of Action	Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A Inhibitors HIV Protease Inhibitors

Suppliers and Packaging for NDA: 216168

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DARUNAVIR	darunavir	TABLET;ORAL	216168	ANDA	Camber Pharmaceuticals, Inc.	31722-088	31722-088-60	60 TABLET, FILM COATED in 1 BOTTLE (31722-088-60)
DARUNAVIR	darunavir	TABLET;ORAL	216168	ANDA	Camber Pharmaceuticals, Inc.	31722-089	31722-089-30	30 TABLET, FILM COATED in 1 BOTTLE (31722-089-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	600MG
Approval Date:	Jan 21, 2025	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	800MG
Approval Date:	Jan 21, 2025	TE:	AB	RLD:	No

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