Details for New Drug Application (NDA): 091055

NDA 091055 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-seven 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 suppliers are listed for this compound. Additional details are available on the emtricitabine; tenofovir disoproxil fumarate profile page.

Summary for 091055

Tradename:	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
Applicant:	Strides Pharma
Ingredient:	emtricitabine; tenofovir disoproxil fumarate
Patents:	0

Pharmacology for NDA: 091055

Mechanism of Action

Nucleoside Reverse Transcriptase Inhibitors

Suppliers and Packaging for NDA: 091055

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	091055	ANDA	Strides Pharma Inc.	42543-719	42543-719-04	30 TABLET in 1 BOTTLE, PLASTIC (42543-719-04)
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	091055	ANDA	Golden State Medical Supply, Inc.	51407-112	51407-112-30	30 TABLET in 1 BOTTLE, PLASTIC (51407-112-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG;300MG
Approval Date:	Jan 13, 2021	TE:	AB	RLD:	No

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