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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 202118

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NDA 202118 describes DARUNAVIR, which is a drug marketed by Amneal, Aurobindo Pharma Ltd, Cipla, Dr Reddys, Hetero Labs Ltd Iii, Lupin Ltd, MSN, Teva Pharms Usa, and Zydus Lifesciences, and is included in nine NDAs. It is available from twelve 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. Thirteen 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

Pharmacology for NDA: 202118

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

Suppliers and Packaging for NDA: 202118

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DARUNAVIR	darunavir	TABLET;ORAL	202118	ANDA	Teva Pharmaceuticals, Inc.	0480-7736	0480-7736-06	60 TABLET, FILM COATED in 1 BOTTLE (0480-7736-06)

Profile for product number 001

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

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