Details for New Drug Application (NDA): 211284

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NDA 211284 describes TEMIXYS, which is a drug marketed by Chartwell Rx and is included in one NDA. Additional details are available on the TEMIXYS profile page.

The generic ingredient in TEMIXYS is lamivudine; tenofovir disoproxil fumarate. There are twenty-nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the lamivudine; tenofovir disoproxil fumarate profile page.

Summary for 211284

Tradename:	TEMIXYS
Applicant:	Chartwell Rx
Ingredient:	lamivudine; tenofovir disoproxil fumarate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	300MG;300MG
Approval Date:	Nov 16, 2018	TE:		RLD:	Yes

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