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Last Updated: December 29, 2025

Details for New Drug Application (NDA): 211337

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NDA 211337 describes TENOFOVIR DISOPROXIL FUMARATE, which is a drug marketed by Aurobindo Pharma, Chartwell, Chartwell Rx, Cipla, Hetero Labs Ltd Iii, Macleods Pharms Ltd, Pharmobedient, Qilu, Reyoung, Strides Pharma, and Teva Pharms Usa, and is included in twelve NDAs. It is available from fifteen suppliers. Additional details are available on the TENOFOVIR DISOPROXIL FUMARATE profile page.

The generic ingredient in TENOFOVIR DISOPROXIL FUMARATE is tenofovir disoproxil fumarate. There are forty-two drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the tenofovir disoproxil fumarate profile page.

Summary for 211337

Tradename:	TENOFOVIR DISOPROXIL FUMARATE
Applicant:	Reyoung
Ingredient:	tenofovir disoproxil fumarate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	300MG
Approval Date:	Mar 2, 2023	TE:	AB	RLD:	No

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