Details for New Drug Application (NDA): 214085

NDA 214085 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 214085

Tradename:	DARUNAVIR
Applicant:	Zydus Lifesciences
Ingredient:	darunavir
Patents:	0

Pharmacology for NDA: 214085

Mechanism of Action

Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A Inhibitors HIV Protease Inhibitors

Suppliers and Packaging for NDA: 214085

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DARUNAVIR	darunavir	TABLET;ORAL	214085	ANDA	Zydus Lifesciences Limited	70771-1745	70771-1745-5	500 TABLET, FILM COATED in 1 BOTTLE (70771-1745-5)
DARUNAVIR	darunavir	TABLET;ORAL	214085	ANDA	Zydus Lifesciences Limited	70771-1745	70771-1745-6	60 TABLET, FILM COATED in 1 BOTTLE (70771-1745-6)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	600MG
Approval Date:	Dec 13, 2023	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	800MG
Approval Date:	Dec 13, 2023	TE:	AB	RLD:	No

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