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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 219152

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NDA 219152 describes ETRAVIRINE, which is a drug marketed by Amneal, Bionpharma, and Carnegie, and is included in three NDAs. It is available from four suppliers. Additional details are available on the ETRAVIRINE profile page.

The generic ingredient in ETRAVIRINE is etravirine. There are five drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the etravirine profile page.

Summary for 219152

Tradename:	ETRAVIRINE
Applicant:	Bionpharma
Ingredient:	etravirine
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Oct 2, 2025	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Oct 2, 2025	TE:	AB	RLD:	No

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