Last Updated: November 13, 2026

Details for New Drug Application (NDA): 209550

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NDA 209550 describes TENOFOVIR DISOPROXIL FUMARATE, which is a drug marketed by Aurobindo Pharma, Chartwell, Chartwell Rx, Cipla, Hetero Labs Ltd Iii, Macleods Pharms, Micro Labs, Pharmobedient, Qilu, Reyoung, Strides Pharma, and Teva Pharms Usa, and is included in thirteen 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 is one drug master file entry for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the tenofovir disoproxil fumarate profile page.

Summary for 209550

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	300MG
Approval Date:	Feb 26, 2018	TE:		RLD:	No

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