Details for New Drug Application (NDA): 203232

NDA 203232 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 203232

Tradename:	TENOFOVIR DISOPROXIL FUMARATE
Applicant:	Macleods Pharms Ltd
Ingredient:	tenofovir disoproxil fumarate
Patents:	0

Pharmacology for NDA: 203232

Mechanism of Action

Nucleoside Reverse Transcriptase Inhibitors

Suppliers and Packaging for NDA: 203232

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TENOFOVIR DISOPROXIL FUMARATE	tenofovir disoproxil fumarate	TABLET;ORAL	203232	ANDA	Major Pharmaceuticals	0904-6821	0904-6821-04	30 BLISTER PACK in 1 CARTON (0904-6821-04) / 1 TABLET in 1 BLISTER PACK
TENOFOVIR DISOPROXIL FUMARATE	tenofovir disoproxil fumarate	TABLET;ORAL	203232	ANDA	Macleods Pharmaceuticals Limited	33342-096	33342-096-07	30 TABLET in 1 BOTTLE (33342-096-07)

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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