Details for New Drug Application (NDA): 090894

NDA 090894 describes EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE, which is a drug marketed by Amneal Pharms Co, Apotex, Aurobindo Pharma, Aurobindo Pharma Ltd, Chartwell Rx, Cipla, Laurus, Macleods Pharms Ltd, Mylan, Strides Pharma, Teva Pharms Usa, and Zydus Pharms, and is included in twelve NDAs. It is available from twenty-eight suppliers. Additional details are available on the EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE profile page.

The generic ingredient in EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE is emtricitabine; tenofovir disoproxil fumarate. There are eighteen drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the emtricitabine; tenofovir disoproxil fumarate profile page.

Summary for 090894

Tradename:	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
Applicant:	Teva Pharms Usa
Ingredient:	emtricitabine; tenofovir disoproxil fumarate
Patents:	0

Pharmacology for NDA: 090894

Mechanism of Action

Nucleoside Reverse Transcriptase Inhibitors

Suppliers and Packaging for NDA: 090894

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	090894	ANDA	Teva Pharmaceuticals USA, Inc.	0093-7704	0093-7704-56	30 TABLET, FILM COATED in 1 BOTTLE (0093-7704-56)
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	090894	ANDA	RedPharm Drug, Inc.	67296-1433	67296-1433-3	3 TABLET, FILM COATED in 1 BOTTLE (67296-1433-3)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG;300MG
Approval Date:	Jun 8, 2017	TE:	AB	RLD:	No

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