Details for New Drug Application (NDA): 021449

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NDA 021449 describes HEPSERA, which is a drug marketed by Gilead and is included in one NDA. Additional details are available on the HEPSERA profile page.

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

Summary for 021449

Tradename:	HEPSERA
Applicant:	Gilead
Ingredient:	adefovir dipivoxil
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Sep 20, 2002	TE:		RLD:	Yes

Expired US Patents for NDA 021449

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead	HEPSERA	adefovir dipivoxil	TABLET;ORAL	021449-001	Sep 20, 2002	⤷ Sign Up	⤷ Sign Up
Gilead	HEPSERA	adefovir dipivoxil	TABLET;ORAL	021449-001	Sep 20, 2002	⤷ Sign Up	⤷ Sign Up
Gilead	HEPSERA	adefovir dipivoxil	TABLET;ORAL	021449-001	Sep 20, 2002	⤷ Sign Up	⤷ Sign Up
Gilead	HEPSERA	adefovir dipivoxil	TABLET;ORAL	021449-001	Sep 20, 2002	⤷ Sign Up	⤷ Sign Up
Gilead	HEPSERA	adefovir dipivoxil	TABLET;ORAL	021449-001	Sep 20, 2002	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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