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Generated: April 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202051

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NDA 202051 describes ADEFOVIR DIPIVOXIL, which is a drug marketed by Sigmapharm Labs Llc and is included in one NDA. It is available from one supplier. Additional details are available on the ADEFOVIR DIPIVOXIL profile page.

The generic ingredient in ADEFOVIR DIPIVOXIL is adefovir dipivoxil. There are eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the adefovir dipivoxil profile page.

Summary for 202051

Tradename:	ADEFOVIR DIPIVOXIL
Applicant:	Sigmapharm Labs Llc
Ingredient:	adefovir dipivoxil
Patents:	0
Therapeutic Class:	Antivirals
Formulation / Manufacturing:	see details

Pharmacology for NDA: 202051

Ingredient-type	Nucleoside Analog
Mechanism of Action	Nucleoside Reverse Transcriptase Inhibitors

Suppliers and Packaging for NDA: 202051

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ADEFOVIR DIPIVOXIL	adefovir dipivoxil	TABLET;ORAL	202051	ANDA	Sigmapharm Laboratories, LLC	42794-003	N	42794-003-08

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Aug 29, 2013	TE:	AB	RLD:	No

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Serving hundreds of leading biopharmaceutical companies globally:

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