Details for New Drug Application (NDA): 021652

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NDA 021652 describes EPZICOM, which is a drug marketed by Viiv Hlthcare and is included in one NDA. It is available from one supplier. Additional details are available on the EPZICOM profile page.

The generic ingredient in EPZICOM is abacavir sulfate; lamivudine. There are twelve drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the abacavir sulfate; lamivudine profile page.

Summary for 021652

Tradename:	EPZICOM
Applicant:	Viiv Hlthcare
Ingredient:	abacavir sulfate; lamivudine
Patents:	0

Pharmacology for NDA: 021652

Mechanism of Action	Cytochrome P450 1A1 Inhibitors Nucleoside Reverse Transcriptase Inhibitors

Suppliers and Packaging for NDA: 021652

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
EPZICOM	abacavir sulfate; lamivudine	TABLET;ORAL	021652	NDA	ViiV Healthcare Company	49702-206	49702-206-13	30 TABLET, FILM COATED in 1 BOTTLE (49702-206-13)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 600MG BASE;300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Aug 2, 2004	TE:		RLD:	Yes

Expired US Patents for NDA 021652

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viiv Hlthcare	EPZICOM	abacavir sulfate; lamivudine	TABLET;ORAL	021652-001	Aug 2, 2004	⤷ Sign Up	⤷ Sign Up
Viiv Hlthcare	EPZICOM	abacavir sulfate; lamivudine	TABLET;ORAL	021652-001	Aug 2, 2004	⤷ Sign Up	⤷ Sign Up
Viiv Hlthcare	EPZICOM	abacavir sulfate; lamivudine	TABLET;ORAL	021652-001	Aug 2, 2004	⤷ Sign Up	⤷ Sign Up
Viiv Hlthcare	EPZICOM	abacavir sulfate; lamivudine	TABLET;ORAL	021652-001	Aug 2, 2004	⤷ Sign Up	⤷ Sign Up
Viiv Hlthcare	EPZICOM	abacavir sulfate; lamivudine	TABLET;ORAL	021652-001	Aug 2, 2004	⤷ Sign Up	⤷ Sign Up
Viiv Hlthcare	EPZICOM	abacavir sulfate; lamivudine	TABLET;ORAL	021652-001	Aug 2, 2004	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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