Details for New Drug Application (NDA): 078800

NDA 078800 describes TENOFOVIR DISOPROXIL FUMARATE, which is a drug marketed by Aurobindo Pharma, Chartwell, Chartwell Rx, Cipla, Hetero Labs Ltd Iii, Macleods Pharms Ltd, Norvium Bioscience, 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 078800

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

Pharmacology for NDA: 078800

Mechanism of Action

Nucleoside Reverse Transcriptase Inhibitors

Suppliers and Packaging for NDA: 078800

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TENOFOVIR DISOPROXIL FUMARATE	tenofovir disoproxil fumarate	TABLET;ORAL	078800	ANDA	Cipla USA Inc.	69097-533	69097-533-02	30 TABLET in 1 BOTTLE (69097-533-02)
TENOFOVIR DISOPROXIL FUMARATE	tenofovir disoproxil fumarate	TABLET;ORAL	078800	ANDA	Cipla USA Inc.	69097-533	69097-533-15	1000 TABLET in 1 BOTTLE (69097-533-15)

Profile for product number 001

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

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