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Last Updated: June 1, 2020

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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 two suppliers. 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. Ten 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
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)
EPZICOM abacavir sulfate; lamivudine TABLET;ORAL 021652 NDA AUTHORIZED GENERIC Prasco Laboratories 66993-482 66993-482-30 30 TABLET, FILM COATED in 1 BOTTLE (66993-482-30)
Paragraph IV (Patent) Challenges for 021652
Tradename Dosage Ingredient NDA Submissiondate
EPZICOM TABLET;ORAL abacavir sulfate; lamivudine 021652 2007-09-27

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 600MG BASE;300MG
Approval Date:Aug 2, 2004TE:ABRLD:Yes

Expired US Patents for NDA 021652

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

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